Hudson RCI
ET Tube, Preformed Uncuffed Nasal, 6.5
9manufacturers in China registered for this device type
241catalogue numbers in this listing
3510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Jiangsu (2), Guangdong (2), Zhejiang (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Hangzhou Jinlin Medical Appliances Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 11 |
| Jiangxi Yikang Medical Instrument Group Co., Ltd. | Nanchang | Jiangxi | Contract manufacturer | 2 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 18 |
| Qingdao Traworks Co., Ltd. | Qingdao | Shandong | Exporter | 7 |
| Tianjin Medis Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 5 |
| Chilecom Medical Devices Co Ltd | Xiangtan | Hunan | Manufacturer | 5 |
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | BTR |
| Device type | Tube, Tracheal (W/Wo Connector) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5730 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K844296 |
| Record published | 2015-10-16 |
| Record revised | 2025-09-29 (version 27) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: None; Storage environment temperature 32 to 122 °F |
| Packaging | Box of 10, case of 10, box of 5, case of 20 |
| Sizes | Length 15 to 1000 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN044802 | Cuffed Reinforced Tracheal Tube, Oral/Nasal | In distribution |
| IPN048957 | Cuffed Reinforced Tracheal Tube, Oral/Nasal | In distribution |
| IPN048953 | Cuffed Reinforced Tracheal Tube, Oral | In distribution |
| IPN048965 | Uncuffed Reinforced Tracheal Tube, Murphy Eye, Oral/Nasal | In distribution |
| IPN048903 | Uncuffed Tracheal Tube Murphy Eye, Oral/Nasal | In distribution |
| IPN048931 | Sheridan Preformed, Cuffed Tracheal Tube, Oral | In distribution |
| IPN044910 | Sheridan Ez-Endo, HVT Cuffed Tracheal Tube With Pre-Loaded Intubating Stylet, Murphy Eye, Oral | In distribution |
| IPN044759 | Cuffed Tracheal Tube Magil Type, Oral/Nasal | In distribution |
| IPN044723 | Length 15 mm | In distribution |
| IPN044916 | Length 15 mm | In distribution |
| IPN048949 | Cuffed Reinforced Tracheal Tube, Oral | In distribution |
| IPN048968 | Uncuffed Reinforced Tracheal Tube, Murphy Eye, Oral/Nasal | In distribution |
| IPN044901 | Sheridan Preformed, Cuffed Tracheal Tube, Oral | In distribution |
| IPN049128 | In distribution | |
| IPN048867 | Cuffed Tracheal Tube Murphy Eye, Oal/Nasal | In distribution |
| IPN048883 | Cuffed Tracheal Tube Magil Type, Oral/Nasal | In distribution |
| IPN044734 | Length 15 mm | In distribution |
| IPN044722 | Length 15 mm | In distribution |
| IPN048886 | Cuffed Tracheal Tube Magil Type, Oral/Nasal | In distribution |
| IPN044794 | Cuffed Reinforced Tracheal Tube, Oral | In distribution |
| IPN048970 | Microlaryngeal Surgical Tracheal Tube, Cuffed, Murphy Eye, Oral/Nasal | In distribution |
| IPN044876 | Length 15 mm | In distribution |
| IPN044891 | Sheridan Preformed, Uncuffed Tracheal Tube, Nasal | In distribution |
| IPN044756 | Cuffed Tracheal Tube Magil Type, Oral/Nasal | In distribution |
| IPN048916 | Sheridan Preformed, Uncuffed Tracheal Tube, Oral | In distribution |
| IPN048900 | Cuffed Tracheal Tube Murphy Eye, Oral/Nasal | In distribution |
| IPN044883 | Length 15 mm | In distribution |
| IPN044730 | Length 15 mm | In distribution |
| IPN048925 | Sheridan Preformed, Uncuffed Tracheal Tube, Nasal | In distribution |
| IPN044882 | Length 15 mm | In distribution |
| IPN044799 | Length 15 mm | In distribution |
| IPN048972 | Microlaryngeal Surgical Tracheal Tube, Cuffed, Murphy Eye, Oral/Nasal | In distribution |
| IPN049130 | Sheridan T.T.X. Tracheal Tube Exchanger | In distribution |
| IPN044884 | Length 15 mm | In distribution |
| IPN048964 | Uncuffed Reinforced Tracheal Tube, Murphy Eye, Oral/Nasal | In distribution |
| IPN048881 | Cuffed Tracheal Tube Magil Type, Oral/Nasal | In distribution |
| IPN048915 | Sheridan Preformed, Uncuffed Tracheal Tube, Oral | In distribution |
| IPN048882 | Cuffed Tracheal Tube Magil Type, Oral/Nasal | In distribution |
| IPN048914 | Sheridan Preformed, Uncuffed Tracheal Tube, Oral | In distribution |
| IPN044721 | Cuffed Tracheal Tube Murphy Eye, Oal/Nasal | In distribution |
| IPN048921 | Sheridan Preformed, Uncuffed Tracheal Tube, Nasal | In distribution |
| IPN048902 | Uncuffed Tracheal Tube Murphy Eye, Oral/Nasal | In distribution |
| IPN044768 | Length 15 mm | In distribution |
| IPN044875 | Length 15 mm | In distribution |
| IPN048952 | Cuffed Reinforced Tracheal Tube, Oral | In distribution |
| IPN044771 | Cuffed Tracheal Tube Murphy Eye, Oral/Nasal | In distribution |
| IPN044912 | Sheridan Ez-Endo, HVT Cuffed Tracheal Tube With Pre-Loaded Intubating Stylet, Murphy Eye, Oral | In distribution |
| IPN044731 | Length 15 mm | In distribution |
| IPN044724 | Cuffed Tracheal Tube Murphy Eye, Oal/Nasal | In distribution |
| IPN044733 | Cuffed Tracheal Tube Murphy Eye, Oal/Nasal | In distribution |
| IPN044919 | Sheridan T.T.X. Tracheal Tube Exchanger | In distribution |
| IPN044791 | Cuffed Reinforced Tracheal Tube, Oral | In distribution |
| IPN044917 | Sheridan Ez-Endo, HVT Cuffed Tracheal Tube With Pre-Loaded Intubating Stylet, Murphy Eye, Oral | In distribution |
| IPN048954 | Cuffed Reinforced Tracheal Tube, Oral | In distribution |
| IPN044798 | Length 15 mm | In distribution |
| IPN044911 | Sheridan Ez-Endo, HVT Cuffed Tracheal Tube With Pre-Loaded Intubating Stylet, Murphy Eye, Oral | In distribution |
| IPN044727 | Length 15 mm | In distribution |
| IPN048944 | Sheridan Preformed, Cuffed Tracheal Tube, Nasal | In distribution |
| IPN044920 | Sheridan T.T.X. Tracheal Tube Exchanger | In distribution |
| IPN044808 | Length 15 mm | In distribution |
| IPN044779 | Length 15 mm | In distribution |
| IPN044886 | Sheridan Preformed, Uncuffed Tracheal Tube, Nasal | In distribution |
| IPN044762 | Length 15 mm | In distribution |
| IPN044773 | Length 15 mm | In distribution |
| IPN044789 | Cuffed Reinforced Tracheal Tube, Oral | In distribution |
| IPN044776 | Uncuffed Tracheal Tube Murphy Eye, Oral/Nasal | In distribution |
| IPN044898 | Length 15 mm | In distribution |
| IPN048960 | Cuffed Reinforced Tracheal Tube, Oral/Nasal | In distribution |
| IPN044778 | Length 15 mm | In distribution |
| IPN044765 | Cuffed Tracheal Tube Murphy Eye, Oral/Nasal | In distribution |
| IPN044786 | Cuffed Reinforced Tracheal Tube, Oral | In distribution |
| IPN044766 | Length 15 mm | In distribution |
| IPN044892 | Length 15 mm | In distribution |
| IPN048947 | Cuffed Reinforced Tracheal Tube, Oral | In distribution |
| IPN044795 | Cuffed Reinforced Tracheal Tube, Oral/Nasal | In distribution |
| IPN048936 | Sheridan Preformed, Cuffed Tracheal Tube, Oral | In distribution |
| IPN044784 | Microlaryngeal Surgical Tracheal Tube, Cuffed, Murphy Eye, Oral/Nasal | In distribution |
| IPN044770 | Length 15 mm | In distribution |
| IPN048864 | Cuffed Tracheal Tube Murphy Eye, Oal/Nasal | In distribution |
| IPN044902 | Sheridan Preformed, Cuffed Tracheal Tube, Oral | In distribution |
| IPN044888 | Length 15 mm | In distribution |
| IPN048884 | Cuffed Tracheal Tube Magil Type, Oral/Nasal | In distribution |
| IPN048946 | Cuffed Reinforced Tracheal Tube, Oral | In distribution |
| IPN048966 | Uncuffed Reinforced Tracheal Tube, Murphy Eye, Oral/Nasal | In distribution |
| IPN048910 | Uncuffed Tracheal Tube Murphy Eye, Oral/Nasal | In distribution |
| IPN044793 | Cuffed Reinforced Tracheal Tube, Oral | In distribution |
| IPN044752 | Length 15 mm | In distribution |
| IPN044763 | Length 15 mm | In distribution |
| IPN044775 | Length 15 mm | In distribution |
| IPN046755 | Length 15 mm | In distribution |
| IPN048938 | Sheridan Preformed, Cuffed Tracheal Tube, Oral | In distribution |
| IPN048870 | Cuffed Tracheal Tube Murphy Eye, Oal/Nasal | In distribution |
| IPN044746 | Cuffed Tracheal Tube Magil Type, Oral/Nasal | In distribution |
| IPN044788 | Cuffed Reinforced Tracheal Tube, Oral | In distribution |
| IPN044885 | Length 15 mm | In distribution |
| IPN048922 | Sheridan Preformed, Uncuffed Tracheal Tube, Nasal | In distribution |
| IPN044777 | Length 15 mm | In distribution |
| IPN048940 | Sheridan Preformed, Cuffed Tracheal Tube, Oral | In distribution |
| IPN044903 | Length 15 mm | In distribution |
| IPN044801 | Cuffed Reinforced Tracheal Tube, Oral/Nasal | In distribution |
| IPN048878 | Cuffed Tracheal Tube Murphy Eye, Oal/Nasal | In distribution |
| IPN048948 | Cuffed Reinforced Tracheal Tube, Oral | In distribution |
| IPN048874 | Cuffed Tracheal Tube Murphy Eye, Oal/Nasal | In distribution |
| IPN048875 | Cuffed Tracheal Tube Murphy Eye, Oal/Nasal | In distribution |
| IPN044726 | Length 15 mm | In distribution |
| IPN048904 | Uncuffed Tracheal Tube Murphy Eye, Oral/Nasal | In distribution |
| IPN048894 | Cuffed Tracheal Tube Murphy Eye, Oral/Nasal | In distribution |
| IPN048887 | Cuffed Tracheal Tube Magil Type, Oral/Nasal | In distribution |
| IPN048919 | Sheridan Preformed, Uncuffed Tracheal Tube, Oral | In distribution |
| IPN044807 | Uncuffed Reinforced Tracheal Tube, Murphy Eye, Oral/Nasal | In distribution |
| IPN048869 | Cuffed Tracheal Tube Murphy Eye, Oal/Nasal | In distribution |
| IPN044880 | Sheridan Preformed, Uncuffed Tracheal Tube, Oral | In distribution |
| IPN048933 | Sheridan Preformed, Cuffed Tracheal Tube, Oral | In distribution |
| IPN044735 | Length 15 mm | In distribution |
| IPN048871 | Cuffed Tracheal Tube Murphy Eye, Oal/Nasal | In distribution |
| IPN048951 | Cuffed Reinforced Tracheal Tube, Oral | In distribution |
| IPN046757 | Length 15 mm | In distribution |
| IPN048898 | Cuffed Tracheal Tube Murphy Eye, Oral/Nasal | In distribution |
| IPN048865 | Cuffed Tracheal Tube Murphy Eye, Oal/Nasal | In distribution |
| IPN044764 | Cuffed Tracheal Tube Murphy Eye, Oral/Nasal | In distribution |
| IPN044800 | Length 15 mm | In distribution |
| IPN044915 | Sheridan Ez-Endo, HVT Cuffed Tracheal Tube With Pre-Loaded Intubating Stylet, Murphy Eye, Oral | In distribution |
| IPN044908 | Sheridan Preformed, Cuffed Tracheal Tube, Nasal | In distribution |
| IPN048920 | Sheridan Preformed, Uncuffed Tracheal Tube, Oral | In distribution |
| IPN048879 | Cuffed Tracheal Tube Magil Type, Oral/Nasal | In distribution |
| IPN048926 | Sheridan Preformed, Uncuffed Tracheal Tube, Nasal | In distribution |
| IPN044909 | Sheridan Ez-Endo, HVT Cuffed Tracheal Tube With Pre-Loaded Intubating Stylet, Murphy Eye, Oral | In distribution |
| IPN044728 | Length 15 mm | In distribution |
| IPN048893 | Cuffed Tracheal Tube Murphy Eye, Oral/Nasal | In distribution |
| IPN048901 | Uncuffed Tracheal Tube Murphy Eye, Oral/Nasal | In distribution |
| IPN048929 | Sheridan Preformed, Uncuffed Tracheal Tube, Nasal | In distribution |
| IPN048943 | Sheridan Preformed, Cuffed Tracheal Tube, Nasal | In distribution |
| IPN048913 | Sheridan Preformed, Uncuffed Tracheal Tube, Oral | In distribution |
| IPN044737 | Length 15 mm | In distribution |
| IPN048912 | Sheridan Preformed, Uncuffed Tracheal Tube, Oral | In distribution |
| IPN044899 | Length 15 mm | In distribution |
| IPN048889 | Cuffed Tracheal Tube Magil Type, Oral/Nasal | In distribution |
| IPN048942 | Sheridan Preformed, Cuffed Tracheal Tube, Nasal | In distribution |
| IPN048909 | Uncuffed Tracheal Tube Murphy Eye, Oral/Nasal | In distribution |
| IPN044796 | Cuffed Reinforced Tracheal Tube, Oral/Nasal | In distribution |
| IPN044732 | Length 15 mm | In distribution |
| IPN048891 | Cuffed Tracheal Tube Murphy Eye, Oral/Nasal | In distribution |
| IPN048892 | Cuffed Tracheal Tube Murphy Eye, Oral/Nasal | In distribution |
| IPN049129 | Sheridan T.T.X. Tracheal Tube Exchanger | In distribution |
| IPN044906 | Length 15 mm | In distribution |
| IPN046756 | Length 15 mm | In distribution |
| IPN049131 | Sheridan T.T.X. Tracheal Tube Exchanger | In distribution |
| IPN044923 | Length 1000 mm | In distribution |
| IPN048962 | Cuffed Reinforced Tracheal Tube, Oral/Nasal | In distribution |
| IPN046758 | Length 15 mm | In distribution |
| IPN048896 | Cuffed Tracheal Tube Murphy Eye, Oral/Nasal | In distribution |
| IPN048928 | Sheridan Preformed, Uncuffed Tracheal Tube, Nasal | In distribution |
| IPN048888 | Cuffed Tracheal Tube Magil Type, Oral/Nasal | In distribution |
| IPN044769 | Length 15 mm | In distribution |
| IPN048906 | Uncuffed Tracheal Tube Murphy Eye, Oral/Nasal | In distribution |
| IPN048877 | Cuffed Tracheal Tube Murphy Eye, Oal/Nasal | In distribution |
| IPN044804 | Uncuffed Reinforced Tracheal Tube, Murphy Eye, Oral/Nasal | In distribution |
| IPN044782 | Uncuffed Tracheal Tube Murphy Eye, Oral/Nasal | In distribution |
| IPN044904 | Length 15 mm | In distribution |
| IPN044753 | Length 15 mm | In distribution |
| IPN044878 | Sheridan Preformed, Uncuffed Tracheal Tube, Oral | In distribution |
| IPN048941 | Sheridan Preformed, Cuffed Tracheal Tube, Nasal | In distribution |
| IPN044774 | Uncuffed Tracheal Tube Murphy Eye, Oral/Nasal | In distribution |
| IPN048959 | Cuffed Reinforced Tracheal Tube, Oral/Nasal | In distribution |
| IPN048897 | Cuffed Tracheal Tube Murphy Eye, Oral/Nasal | In distribution |
| IPN048939 | Sheridan Preformed, Cuffed Tracheal Tube, Oral | In distribution |
| IPN048908 | Uncuffed Tracheal Tube Murphy Eye, Oral/Nasal | In distribution |
| IPN044894 | Length 15 mm | In distribution |
| IPN048955 | Cuffed Reinforced Tracheal Tube, Oral/Nasal | In distribution |
| IPN044922 | Sheridan T.T.X. Tracheal Tube Exchanger | In distribution |
| IPN048927 | Sheridan Preformed, Uncuffed Tracheal Tube, Nasal | In distribution |
| IPN044889 | Sheridan Preformed, Uncuffed Tracheal Tube, Nasal | In distribution |
| IPN044907 | Sheridan Preformed, Cuffed Tracheal Tube, Nasal | In distribution |
| IPN048958 | Cuffed Reinforced Tracheal Tube, Oral/Nasal | In distribution |
| IPN044757 | Length 15 mm | In distribution |
| IPN044797 | Length 15 mm | In distribution |
| IPN044783 | Microlaryngeal Surgical Tracheal Tube, Cuffed, Murphy Eye, Oral/Nasal | In distribution |
| IPN044781 | Length 15 mm | In distribution |
| IPN044887 | Length 15 mm | In distribution |
| IPN044772 | Uncuffed Tracheal Tube Murphy Eye, Oral/Nasal | In distribution |
| IPN048956 | Cuffed Reinforced Tracheal Tube, Oral/Nasal | In distribution |
| IPN048963 | Cuffed Reinforced Tracheal Tube, Oral/Nasal | In distribution |
| IPN048866 | Cuffed Tracheal Tube Murphy Eye, Oal/Nasal | In distribution |
| IPN044785 | Length 15 mm | In distribution |
| IPN048876 | Cuffed Tracheal Tube Murphy Eye, Oal/Nasal | In distribution |
| IPN044749 | Length 15 mm | In distribution |
| IPN048868 | Cuffed Tracheal Tube Murphy Eye, Oal/Nasal | In distribution |
| IPN044897 | Sheridan Preformed, Cuffed Tracheal Tube, Oral | In distribution |
| IPN044767 | Length 15 mm | In distribution |
| IPN048961 | Cuffed Reinforced Tracheal Tube, Oral/Nasal | In distribution |
| IPN048880 | Cuffed Tracheal Tube Magil Type, Oral/Nasal | In distribution |
| IPN044755 | Length 15 mm | In distribution |
| IPN044803 | Cuffed Reinforced Tracheal Tube, Oral/Nasal | In distribution |
| IPN044895 | Sheridan Preformed, Cuffed Tracheal Tube, Oral | In distribution |
| IPN048899 | Cuffed Tracheal Tube Murphy Eye, Oral/Nasal | In distribution |
| IPN048885 | Cuffed Tracheal Tube Magil Type, Oral/Nasal | In distribution |
| IPN048917 | Sheridan Preformed, Uncuffed Tracheal Tube, Oral | In distribution |
| IPN044780 | Length 15 mm | In distribution |
| IPN044751 | Length 15 mm | In distribution |
| IPN044729 | Length 15 mm | In distribution |
| IPN044787 | Length 15 mm | In distribution |
| IPN044913 | Sheridan Ez-Endo, HVT Cuffed Tracheal Tube With Pre-Loaded Intubating Stylet, Murphy Eye, Oral | In distribution |
| IPN044750 | Cuffed Tracheal Tube Magil Type, Oral/Nasal | In distribution |
| IPN044921 | Length 810 mm | In distribution |
| IPN044790 | Length 15 mm | In distribution |
| IPN048905 | Uncuffed Tracheal Tube Murphy Eye, Oral/Nasal | In distribution |
| IPN048937 | Sheridan Preformed, Cuffed Tracheal Tube, Oral | In distribution |
| IPN044806 | Uncuffed Reinforced Tracheal Tube, Murphy Eye, Oral/Nasal | In distribution |
| IPN048971 | Microlaryngeal Surgical Tracheal Tube, Cuffed, Murphy Eye, Oral/Nasal | In distribution |
| IPN044914 | Length 15 mm | In distribution |
| IPN048890 | Cuffed Tracheal Tube Magil Type, Oral/Nasal | In distribution |
| IPN048873 | Cuffed Tracheal Tube Murphy Eye, Oal/Nasal | In distribution |
| IPN046759 | Length 15 mm | In distribution |
| IPN044754 | Cuffed Tracheal Tube Magil Type, Oral/Nasal | In distribution |
| IPN044881 | Length 15 mm | In distribution |
| IPN048923 | Sheridan Preformed, Uncuffed Tracheal Tube, Nasal | In distribution |
| IPN048950 | Cuffed Reinforced Tracheal Tube, Oral | In distribution |
| IPN044792 | Cuffed Reinforced Tracheal Tube, Oral | In distribution |
| IPN048967 | Uncuffed Reinforced Tracheal Tube, Murphy Eye, Oral/Nasal | In distribution |
| IPN046761 | Sheridan/HVT Cuffed, Murphy Eye | In distribution |
| IPN048932 | Sheridan Preformed, Cuffed Tracheal Tube, Oral | In distribution |
| IPN048935 | Sheridan Preformed, Cuffed Tracheal Tube, Oral | In distribution |
| IPN048924 | Sheridan Preformed, Uncuffed Tracheal Tube, Nasal | In distribution |
| IPN048930 | Sheridan Preformed, Cuffed Tracheal Tube, Oral | In distribution |
| IPN044896 | Sheridan Preformed, Cuffed Tracheal Tube, Oral | In distribution |
| IPN048911 | Uncuffed Tracheal Tube Murphy Eye, Oral/Nasal | In distribution |
| IPN048907 | Uncuffed Tracheal Tube Murphy Eye, Oral/Nasal | In distribution |
| IPN044893 | Length 15 mm | In distribution |
| IPN048895 | Cuffed Tracheal Tube Murphy Eye, Oral/Nasal | In distribution |
| IPN044890 | Length 15 mm | In distribution |
| IPN044747 | Length 15 mm | In distribution |
| IPN044805 | Uncuffed Reinforced Tracheal Tube, Murphy Eye, Oral/Nasal | In distribution |
| IPN044905 | Length 15 mm | In distribution |
| IPN048918 | Sheridan Preformed, Uncuffed Tracheal Tube, Oral | In distribution |
| IPN048945 | Sheridan Preformed, Cuffed Tracheal Tube, Nasal | In distribution |
| IPN044877 | Sheridan Preformed, Uncuffed Tracheal Tube, Oral | In distribution |
| IPN048872 | Cuffed Tracheal Tube Murphy Eye, Oal/Nasal | In distribution |
| IPN048934 | Sheridan Preformed, Cuffed Tracheal Tube, Oral | In distribution |
| IPN044900 | Sheridan Preformed, Cuffed Tracheal Tube, Oral | In distribution |
| IPN044879 | Length 15 mm | In distribution |
| IPN046760 | Length 15 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rusch | Teleflex Medical LLC | 301 |
| Shiley | Covidien LP | 295 |
| Mallinckrodt | Covidien LP | 258 |
| Portex | ICU Medical, Inc | 208 |
| Parker Flex-Tip | Salter Labs | 164 |
| Parker | Salter Labs | 157 |
| Curaplex | Bound Tree Medical, LLC | 149 |
| SourceMark | Sourcemark, LLC. | 148 |
| Montgomery® Safe-T-Tube™ | Boston Medical Products, Inc. | 144 |
| Sunmed | SunMed Group Holdings, LLC | 112 |
| Forsure | Forsure Medical Products LLC. | 101 |
| Sheridan | Teleflex Medical LLC | 100 |
Showing 12 of 374. All products under Tube, Tracheal (W/Wo Connector)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242495 | 2025-04-29 |
| K241451 | 2025-02-11 |
| K043205 | 2005-01-07 |
Recalls Naming This Product
27 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Teleflex Medical LLC | 510(k) number | 2019-07-30 | Class I | Process control | Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, re | 7963 units | 2022-02-15 |
| Teleflex Medical LLC | 510(k) number | 2019-07-30 | Class I | Process control | Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, re | 1805730 units | 2022-02-15 |
| Teleflex Medical LLC | 510(k) number | 2019-07-30 | Class I | Process control | Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, re | 57181units | 2022-02-15 |
| Teleflex Medical LLC | 510(k) number | 2019-07-30 | Class I | Process control | Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, re | 278142 units | 2022-02-15 |
| Teleflex Medical LLC | 510(k) number | 2019-07-30 | Class I | Process control | Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, re | 170740 units | 2022-02-15 |
| Teleflex Medical LLC | 510(k) number | 2019-07-30 | Class I | Process control | Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, re | 3375808 units | 2022-02-15 |
| Teleflex Medical LLC | 510(k) number | 2019-07-30 | Class I | Process control | Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, re | 77136 units | 2022-02-15 |
| Teleflex Medical LLC | 510(k) number | 2019-07-30 | Class I | Process control | Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, re | 1391004 units | 2022-02-15 |
| Centurion Medical Products, LP | 510(k) number | 2019-06-07 | Class I | Device Design | Centurion is conducting a sub-recall for Teleflex Sheridan branded Endotracheal Tracheal Tubes due to increased incidence of Sheridan connector becoming disconnected from Endotracheal Tube. | 80 kits | 2020-07-28 |
| Teleflex Medical LLC | 510(k) number | 2019-05-24 | Class I | Process control | This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the Endotracheal | 3483 units | 2022-02-15 |
| Teleflex Medical LLC | 510(k) number | 2019-05-24 | Class I | Process control | This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the Endotracheal | 1101073 units | 2022-02-15 |
| Teleflex Medical LLC | 510(k) number | 2019-05-24 | Class I | Process control | This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the Endotracheal | 55312 units | 2022-02-15 |
| Teleflex Medical LLC | 510(k) number | 2019-05-24 | Class I | Process control | This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the Endotracheal | 186592 units | 2022-02-15 |
| Teleflex Medical LLC | 510(k) number | 2019-05-24 | Class I | Process control | This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the Endotracheal | 14357 | 2022-02-15 |
| Teleflex Medical LLC | 510(k) number | 2019-05-24 | Class I | Process control | This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the Endotracheal | 3238600 units | 2022-02-15 |
| Teleflex Medical LLC | 510(k) number | 2019-05-24 | Class I | Process control | This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the Endotracheal | 77136 units | 2022-02-15 |
| Teleflex Medical LLC | 510(k) number | 2019-05-24 | Class I | Process control | This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the Endotracheal | 1390944 units | 2022-02-15 |
| Teleflex Medical LLC | 510(k) number | 2016-10-18 | Class II | Other | Labeling inconsistency – units labeled with a 7mm tube may contain a size 6.5mm tube, and units labeled 7.5mm tube may contain a size 5.5mm tube. | 25,274 units | 2017-08-25 |
| Teleflex Medical LLC | 510(k) number | 2016-05-05 | Class II | Error in labeling | The labeling of some units indicates that it contains a size 7mm tracheal tube, but may contain a size 7.5mm tracheal tube. | 6,390 ea. | 2017-08-25 |
| Teleflex Medical LLC | 510(k) number | 2015-01-09 | Class II | Labeling mix-ups | Labeling; The affected product packaging is incorrectly labeled as being a cuffed oral ET tube; The correct product labeling is uncuffed nasal ET tube. | 300 units | 2016-09-27 |
| Teleflex Medical LLC | 510(k) number | 2014-11-12 | Class II | Process control | Product Labeling; Units from the affected lot indicates that it contains a size 8mm tracheal tube but may contain a size 7.5mm tracheal tube. | 14,000 units | 2017-10-13 |
| Teleflex Medical LLC | 510(k) number | 2009-07-06 | Not classified | Process control | The Nasal Preformed Tracheal Tubes were found to have incorrect insertion depth mark printings. | 1160 total | 2010-08-24 |
| Teleflex Medical LLC | 510(k) number | 2009-07-06 | Not classified | Process control | The Nasal Preformed Tracheal Tubes were found to have incorrect insertion depth mark printings. | 1160 total | 2010-08-24 |
| Teleflex Medical LLC | 510(k) number | 2006-09-27 | Not classified | Other | Biological indicator failed. Investigation eliminated all equipment and product related factors. | 280 units | 2009-08-12 |
| Teleflex Medical LLC | 510(k) number | 2006-09-27 | Not classified | Other | Biological indicator failed. Investigation eliminated all equipment and product related factors. | 830 units | 2009-08-12 |
| Teleflex Medical LLC | 510(k) number | 2006-09-27 | Not classified | Other | Biological indicator failed. Investigation eliminated all equipment and product related factors. | 990 units | 2009-08-12 |
| Teleflex Medical LLC | 510(k) number | 2005-01-14 | Not classified | Other | Some of the primary labels have the internal diameter (ID) and outer diameter (OD) numbers reversed, i.e. ID 10.9 mm and OD 8.0 mm instead of the actual ID 8.0 and OD 10.9 mm, mislabeling the size of the tracheal tube. | 8,990 units | 2005-08-19 |
Recalls
40 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2023-05-25 | Class I | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | 2874 units |
| 2023-05-25 | Class I | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | 4370 units |
| 2023-05-25 | Class I | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | 24752 units |
| 2023-05-25 | Class I | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | 3843 units |
| 2023-05-25 | Class I | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | 76060 units |
| 2023-05-25 | Class I | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | 36135 units |
| 2023-05-25 | Class I | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | 11560 units |
| 2023-05-25 | Class I | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | 1110 units |
| 2023-05-25 | Class I | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | 2714 units |
| 2023-05-25 | Class I | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | 670 units |
| 2023-05-25 | Class I | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | 11188 units |
| 2023-05-25 | Class I | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | 16400 units |
| 2023-05-25 | Class I | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | 302652 units |
| 2023-05-25 | Class I | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | 2382 units |
| 2023-05-25 | Class I | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | 4769 units |
| 2023-05-25 | Class I | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | 92930 units |
| 2023-05-25 | Class I | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | 25630 units |
| 2023-05-25 | Class I | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | 16570 units |
| 2023-05-25 | Class I | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | 14160 units |
| 2023-05-25 | Class I | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | 3309 units |
| 2023-05-25 | Class I | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | 18150 units |
| 2023-05-25 | Class I | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | 25160 units |
| 2023-05-25 | Class I | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | 15810 units |
| 2023-05-25 | Class I | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | 37890 units |
| 2023-05-25 | Class I | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | 170610 units |
| 2023-05-25 | Class I | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | 10600 units |
| 2023-05-25 | Class I | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | 43571 units |
| 2023-05-25 | Class I | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | 684042 units |
| 2023-05-25 | Class I | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | 54469 units |
| 2023-05-25 | Class I | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | 4160 units |
| 2023-05-25 | Class I | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | 30391 units |
| 2023-05-25 | Class I | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | 446163 units |
| 2023-05-25 | Class I | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | 50039 units |
| 2023-05-25 | Class I | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | 3100 units |
| 2023-05-25 | Class I | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | 12382 units |
| 2023-05-25 | Class I | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | 190 units |
| 2023-05-25 | Class I | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | 13810 units |
| 2023-05-25 | Class I | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | 510 units |
| 2023-05-25 | Class I | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | 3590 units |
| 2023-05-25 | Class I | Under Investigation by firm | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | 8620 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.