Rusch
Preformed AGT Nasal Endotracheal Tube - Murphy EYE, High Volume, LOW Pressure Cuff - Sterile Pack
9manufacturers in China registered for this device type
301catalogue 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) | K132415 |
| Record published | 2015-10-16 |
| Record revised | 2025-03-18 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep away from sunlight; Keep dry |
| Packaging | Box of 10, case of 10, box of 2, box of 5, case of 16, carton of 98 |
| Sizes | Outer diameter 3 to 15 mm; width 25 to 50 mm; length 150 to 455 mm; height 16.5 to 35 mm; lumen/inner diameter 2 to 11 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| IPN041634 | Width 26 mm | In distribution | |
| IPN046832 | Height 16.5 mm | In distribution | |
| IPN040976 | Height 35 mm | In distribution | |
| IPN040700 | Length 228 mm | In distribution | |
| IPN040963 | Outer Diameter 6.3 mm | In distribution | |
| IPN039526 | In distribution | ||
| IPN040756 | Width 25 mm | In distribution | |
| IPN040859 | Lumen/Inner Diameter 3.5 mm | In distribution | |
| IPN040776 | Outer Diameter 4.7 mm | In distribution | |
| IPN041614 | Height 16.5 mm | In distribution | |
| IPN040754 | Outer Diameter 4 mm | In distribution | |
| IPN041547 | Outer Diameter 6 mm | In distribution | |
| IPN040860 | Lumen/Inner Diameter 4 mm | In distribution | |
| IPN928691 | Length 334 mm | In distribution | |
| IPN040982 | Outer Diameter 9.8 mm | In distribution | |
| IPN044689 | Lumen/Inner Diameter 9 mm | In distribution | |
| IPN914382 | In distribution | ||
| IPN044607 | 3.5 mm | 10 | In distribution |
| IPN041582 | Length 300 mm | In distribution | |
| IPN928688 | Length 321 mm | In distribution | |
| IPN040758 | Height 16.5 mm | In distribution | |
| IPN042742 | Height 28 mm | In distribution | |
| IPN041623 | Height 29 mm | In distribution | |
| IPN039521 | In distribution | ||
| IPN928698 | Outer Diameter 12.9 mm | In distribution | |
| IPN044697 | Height 16.5 mm | In distribution | |
| IPN042501 | Length 280 mm | In distribution | |
| IPN914379 | In distribution | ||
| IPN041446 | Height 18 mm | In distribution | |
| IPN041503 | Width 28 mm | In distribution | |
| IPN044613 | 6.5 mm | 10 | In distribution |
| IPN041579 | Width 25 mm | In distribution | |
| IPN041442 | Length 255 mm | In distribution | |
| IPN914320 | Lumen/Inner Diameter 4 mm | In distribution | |
| IPN041457 | Height 20 mm | In distribution | |
| IPN041577 | Width 25 mm | In distribution | |
| IPN041450 | Length 385 mm | In distribution | |
| IPN040898 | Lumen/Inner Diameter 5 mm | In distribution | |
| IPN040757 | Outer Diameter 6 mm | In distribution | |
| IPN041589 | Width 29 mm | In distribution | |
| IPN042500 | Length 250 mm | In distribution | |
| IPN042735 | Width 35 mm | In distribution | |
| IPN044694 | Width 50 mm | In distribution | |
| IPN041445 | Width 25 mm | In distribution | |
| IPN041575 | Height 16.5 mm | In distribution | |
| IPN041419 | Width 25 mm | In distribution | |
| IPN040870 | I.D. 9.0 | In distribution | |
| IPN040972 | Length 388 mm | In distribution | |
| IPN040783 | Width 25 mm | In distribution | |
| IPN040949 | Outer Diameter 5.5 mm | In distribution | |
| IPN040863 | I.D. 5.5 | In distribution | |
| IPN040858 | I.D. 3.0 | In distribution | |
| IPN044682 | Lumen/Inner Diameter 5.5 mm | In distribution | |
| IPN040714 | Outer Diameter 4.7 mm | In distribution | |
| IPN040862 | Lumen/Inner Diameter 5 mm | In distribution | |
| IPN040872 | I.D. 10 | In distribution | |
| IPN040952 | Lumen/Inner Diameter 5 mm | In distribution | |
| IPN040900 | Lumen/Inner Diameter 7 mm | In distribution | |
| IPN040975 | Length 399 mm | In distribution | |
| IPN040718 | Height 16.5 mm | In distribution | |
| IPN044683 | Lumen/Inner Diameter 6 mm | In distribution | |
| IPN040760 | Height 16.5 mm | In distribution | |
| IPN040775 | Height 16.5 mm | In distribution | |
| IPN040701 | Width 25 mm | In distribution | |
| IPN040867 | I.D. 7.5 | In distribution | |
| IPN040717 | Height 16.5 mm | In distribution | |
| IPN040696 | Outer Diameter 4 mm | In distribution | |
| IPN040753 | Height 16.5 mm | In distribution | |
| IPN041422 | Outer Diameter 6.7 mm | In distribution | |
| IPN041585 | Height 26 mm | In distribution | |
| IPN042497 | Lumen/Inner Diameter 3.5 mm | In distribution | |
| IPN042739 | Lumen/Inner Diameter 6 mm | In distribution | |
| IPN928687 | Width 25 mm | In distribution | |
| IPN040969 | Outer Diameter 9.6 mm | In distribution | |
| IPN044693 | Width 50 mm | In distribution | |
| IPN044622 | 11.0 mm | 10 | In distribution |
| IPN044621 | 10.5 mm | 10 | In distribution |
| IPN046819 | Height 16.5 mm | In distribution | |
| IPN040978 | Outer Diameter 7.8 mm | In distribution | |
| IPN046830 | Length 320 mm | In distribution | |
| IPN041499 | Length 280 mm | In distribution | |
| IPN044686 | Lumen/Inner Diameter 7.5 mm | In distribution | |
| IPN042744 | Lumen/Inner Diameter 8.5 mm | In distribution | |
| IPN040704 | Width 25 mm | In distribution | |
| IPN040703 | Width 25 mm | In distribution | |
| IPN914377 | In distribution | ||
| IPN044685 | Lumen/Inner Diameter 7 mm | In distribution | |
| IPN041423 | Width 25 mm | In distribution | |
| IPN928690 | Outer Diameter 8.4 mm | In distribution | |
| IPN039524 | In distribution | ||
| IPN040995 | 7.0 | In distribution | |
| IPN044605 | 2.5 mm | 10 | In distribution |
| IPN041504 | Height 30 mm | In distribution | |
| IPN041479 | Length 300 mm | In distribution | |
| IPN046822 | Outer Diameter 9.3 mm | In distribution | |
| IPN044684 | Lumen/Inner Diameter 6.5 mm | In distribution | |
| IPN040962 | Height 16.5 mm | In distribution | |
| IPN042743 | Length 345 mm | In distribution | |
| IPN044619 | 9.5 mm | 10 | In distribution |
| IPN040984 | Outer Diameter 10.8 mm | In distribution | |
| IPN041639 | Length 350 mm | In distribution | |
| IPN046823 | Outer Diameter 10 mm | In distribution | |
| IPN041574 | Height 16.5 mm | In distribution | |
| IPN044696 | Length 230 mm | In distribution | |
| IPN040947 | 2.5 | In distribution | |
| IPN041638 | Width 29 mm | In distribution | |
| IPN046821 | Length 300 mm | In distribution | |
| IPN041483 | Height 30 mm | In distribution | |
| IPN928696 | Outer Diameter 11.9 mm | In distribution | |
| IPN040979 | Lumen/Inner Diameter 5.5 mm | In distribution | |
| IPN040901 | 8.0 | In distribution | |
| IPN044617 | 8.5 mm | 10 | In distribution |
| IPN041461 | Height 28 mm | In distribution | |
| IPN041578 | Height 16.5 mm | In distribution | |
| IPN041424 | Height 18 mm | In distribution | |
| IPN041616 | Width 25 mm | In distribution | |
| IPN041629 | Outer Diameter 7.3 mm | In distribution | |
| IPN040716 | Outer Diameter 6 mm | In distribution | |
| IPN041458 | Width 25 mm | In distribution | |
| IPN041485 | Width 34 mm | In distribution | |
| IPN041615 | Width 25 mm | In distribution | |
| IPN041506 | Height 34 mm | In distribution | |
| IPN041580 | Outer Diameter 7.3 mm | In distribution | |
| IPN040966 | Outer Diameter 7.8 mm | In distribution | |
| IPN040864 | Lumen/Inner Diameter 6 mm | In distribution | |
| IPN041583 | Length 320 mm | In distribution | |
| IPN046818 | Height 16.5 mm | In distribution | |
| IPN040781 | Height 16.5 mm | In distribution | |
| IPN046820 | Outer Diameter 8 mm | In distribution | |
| IPN042494 | Height 16.5 mm | In distribution | |
| IPN041635 | Width 28 mm | In distribution | |
| IPN040778 | Height 16.5 mm | In distribution | |
| IPN041548 | Length 230 mm | In distribution | |
| IPN041546 | Outer Diameter 5.3 mm | In distribution | |
| IPN044695 | Height 16.5 mm | In distribution | |
| IPN914319 | Lumen/Inner Diameter 3.5 mm | In distribution | |
| IPN041624 | Width 29 mm | In distribution | |
| IPN928686 | Width 25 mm | In distribution | |
| IPN041618 | Outer Diameter 10 mm | In distribution | |
| IPN041588 | Length 350 mm | In distribution | |
| IPN042741 | Lumen/Inner Diameter 7 mm | In distribution | |
| IPN040968 | Length 334 mm | In distribution | |
| IPN044606 | 3.0 mm | 10 | In distribution |
| IPN041480 | Outer Diameter 9.3 mm | In distribution | |
| IPN041544 | Outer Diameter 4 mm | In distribution | |
| IPN041443 | Width 25 mm | In distribution | |
| IPN040986 | Lumen/Inner Diameter 9 mm | In distribution | |
| IPN914321 | Lumen/Inner Diameter 4.5 mm | In distribution | |
| IPN040702 | Length 253 mm | In distribution | |
| IPN041444 | Outer Diameter 6.7 mm | In distribution | |
| IPN040899 | 6.0 | In distribution | |
| IPN041500 | Height 24 mm | In distribution | |
| IPN040857 | Lumen/Inner Diameter 2.5 mm | In distribution | |
| IPN041448 | Length 365 mm | In distribution | |
| IPN039522 | In distribution | ||
| IPN040950 | 4.0 | In distribution | |
| IPN040873 | I.D. 10.5 | In distribution | |
| IPN041619 | Length 320 mm | In distribution | |
| IPN914317 | Outer Diameter 3.3 mm | In distribution | |
| IPN042498 | Lumen/Inner Diameter 4 mm | In distribution | |
| IPN040998 | Lumen/Inner Diameter 8.5 mm | In distribution | |
| IPN040699 | Outer Diameter 6 mm | In distribution | |
| IPN040997 | 8.0 | In distribution | |
| IPN042737 | Length 280 mm | In distribution | |
| IPN042496 | Height 16.5 mm | In distribution | |
| IPN040871 | I.D. 9.5 | In distribution | |
| IPN042738 | Lumen/Inner Diameter 5.5 mm | In distribution | |
| IPN041430 | Outer Diameter 12 mm | In distribution | |
| IPN046825 | Width 28 mm | In distribution | |
| IPN041505 | Width 30 mm | In distribution | |
| IPN040777 | Height 16.5 mm | In distribution | |
| IPN042499 | Height 16.5 mm | In distribution | |
| IPN928692 | Width 28 mm | In distribution | |
| IPN046826 | Height 28 mm | In distribution | |
| IPN041581 | Height 18.5 mm | In distribution | |
| IPN040868 | I.D. 8.0 | In distribution | |
| IPN041498 | Outer Diameter 6.7 mm | In distribution | |
| IPN044614 | 7.0 mm | 10 | In distribution |
| IPN040970 | Height 28 mm | In distribution | |
| IPN044616 | 8.0 mm | 10 | In distribution |
| IPN044610 | 5.0 mm | 10 | In distribution |
| IPN040980 | Lumen/Inner Diameter 6 mm | In distribution | |
| IPN046831 | Length 330 mm | In distribution | |
| IPN040981 | 6.5 | In distribution | |
| IPN928693 | Width 28 mm | In distribution | |
| IPN041441 | Height 16.5 mm | In distribution | |
| IPN044618 | 9.0 mm | 10 | In distribution |
| IPN040992 | Lumen/Inner Diameter 5.5 mm | In distribution | |
| IPN040951 | Outer Diameter 6.5 mm | In distribution | |
| IPN041620 | Outer Diameter 11.6 mm | In distribution | |
| IPN040866 | I.D. 7.0 | In distribution | |
| IPN044623 | Gr.10.5 | 10 | In distribution |
| IPN040865 | I.D. 6.5 | In distribution | |
| IPN041630 | Outer Diameter 8 mm | In distribution | |
| IPN042740 | Length 320 mm | In distribution | |
| IPN041459 | Outer Diameter 10 mm | In distribution | |
| IPN040713 | Length 175 mm | In distribution | |
| IPN041501 | Length 300 mm | In distribution | |
| IPN040994 | Outer Diameter 9.3 mm | In distribution | |
| IPN041482 | Length 340 mm | In distribution | |
| IPN041507 | Length 350 mm | In distribution | |
| IPN040971 | Outer Diameter 10.8 mm | In distribution | |
| IPN039527 | In distribution | ||
| IPN044615 | 7.5 mm | 10 | In distribution |
| IPN040964 | Length 259 mm | In distribution | |
| IPN040720 | Outer Diameter 8.7 mm | In distribution | |
| IPN041508 | Width 34 mm | In distribution | |
| IPN044692 | Width 50 mm | In distribution | |
| IPN040774 | Outer Diameter 3.3 mm | In distribution | |
| IPN040874 | Lumen/Inner Diameter 11 mm | In distribution | |
| IPN041449 | Outer Diameter 10 mm | In distribution | |
| IPN041633 | Length 320 mm | In distribution | |
| IPN042746 | Height 34 mm | In distribution | |
| IPN040999 | 9.0 | In distribution | |
| IPN041586 | Outer Diameter 11.3 mm | In distribution | |
| IPN041428 | Length 305 mm | In distribution | |
| IPN041427 | Outer Diameter 10 mm | In distribution | |
| IPN914378 | In distribution | ||
| IPN928694 | Height 31 mm | In distribution | |
| IPN046833 | Length 330 mm | In distribution | |
| IPN928685 | Outer Diameter 5.8 mm | In distribution | |
| IPN914323 | Outer Diameter 7.3 mm | In distribution | |
| IPN040755 | Outer Diameter 4.7 mm | In distribution | |
| IPN041486 | Height 34 mm | In distribution | |
| IPN041587 | Width 28 mm | In distribution | |
| IPN041447 | Height 20 mm | In distribution | |
| IPN040954 | Lumen/Inner Diameter 6 mm | In distribution | |
| IPN040759 | Height 16.5 mm | In distribution | |
| IPN040991 | Lumen/Inner Diameter 5 mm | In distribution | |
| IPN041481 | Outer Diameter 10 mm | In distribution | |
| IPN041425 | Length 263 mm | In distribution | |
| IPN914316 | Lumen/Inner Diameter 2 mm | In distribution | |
| IPN041429 | Outer Diameter 11.3 mm | In distribution | |
| IPN041622 | Outer Diameter 13 mm | In distribution | |
| IPN040719 | Width 25 mm | In distribution | |
| IPN914383 | In distribution | ||
| IPN040869 | I.D. 8.5 | In distribution | |
| IPN041477 | Height 20 mm | In distribution | |
| IPN040715 | Length 225 mm | In distribution | |
| IPN046829 | Width 25 mm | In distribution | |
| IPN039525 | In distribution | ||
| IPN928697 | Outer Diameter 12.4 mm | In distribution | |
| IPN039523 | In distribution | ||
| IPN041484 | Outer Diameter 12 mm | In distribution | |
| IPN044603 | 1.5 mm | 10 | In distribution |
| IPN041426 | Length 278 mm | In distribution | |
| IPN041631 | Length 290 mm | In distribution | |
| IPN040953 | 5.5 | In distribution | |
| IPN040996 | 7.5 | In distribution | |
| IPN040973 | Height 35 mm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Shiley | Covidien LP | 295 |
| Mallinckrodt | Covidien LP | 258 |
| Hudson RCI | Teleflex Medical LLC | 241 |
| 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
139 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | 510(k) number | 2024-02-26 | Class I | Under Investigation by firm | Complaints have been received that the device inflation tube detached and/or tore from the main tube, resulting in potential moisture buildup, loss of pressure, or inability to inflate. There were also reports the suction pump is difficult | 168,632 tubes and 13,092 kits |
| Teleflex Medical LLC | 510(k) number | 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 |
| Teleflex Medical LLC | 510(k) number | 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. | 3530 units |
| Teleflex Medical LLC | 510(k) number | 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. | 9400 units |
| Teleflex Medical LLC | 510(k) number | 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. | 15020 |
| Teleflex Medical LLC | 510(k) number | 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 |
| Teleflex Medical LLC | 510(k) number | 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. | 38950 units |
| Teleflex Medical LLC | 510(k) number | 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 |
| Teleflex Medical LLC | 510(k) number | 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 |
| Teleflex Medical LLC | 510(k) number | 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. | 1460 units |
| Teleflex Medical LLC | 510(k) number | 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. | 720 units |
| Teleflex Medical LLC | 510(k) number | 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 |
| Teleflex Medical LLC | 510(k) number | 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. | 18900 units |
| Teleflex Medical LLC | 510(k) number | 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. | 22400 units |
| Teleflex Medical LLC | 510(k) number | 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. | 20662 units |
| Teleflex Medical LLC | 510(k) number | 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. | 10650 units |
| Teleflex Medical LLC | 510(k) number | 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. | 4320 units |
| Teleflex Medical LLC | 510(k) number | 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. | 2940 units |
| Teleflex Medical LLC | 510(k) number | 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. | 3310 units |
| Teleflex Medical LLC | 510(k) number | 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. | 66310 units |
| Teleflex Medical LLC | 510(k) number | 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. | 42214 units |
| Teleflex Medical LLC | 510(k) number | 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. | 103842 units |
| Teleflex Medical LLC | 510(k) number | 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 |
| Teleflex Medical LLC | 510(k) number | 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. | 1051810 units |
| Teleflex Medical LLC | 510(k) number | 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 |
| Teleflex Medical LLC | 510(k) number | 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. | 244120 units |
| Teleflex Medical LLC | 510(k) number | 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. | 56640 units |
| Teleflex Medical LLC | 510(k) number | 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. | 13710 units |
| Teleflex Medical LLC | 510(k) number | 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. | 17551 units |
| Teleflex Medical LLC | 510(k) number | 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. | 32553 units |
| Teleflex Medical LLC | 510(k) number | 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. | 18353 units |
| Teleflex Medical LLC | 510(k) number | 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 |
| Teleflex Medical LLC | 510(k) number | 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. | 12400 units |
| Teleflex Medical LLC | 510(k) number | 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 |
| Teleflex Medical LLC | 510(k) number | 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 |
| Teleflex Medical LLC | 510(k) number | 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 |
| Teleflex Medical LLC | 510(k) number | 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 |
| Teleflex Medical LLC | 510(k) number | 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. | 5120 units |
| Teleflex Medical LLC | 510(k) number | 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. | 4155 units |
| Teleflex Medical LLC | 510(k) number | 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. | 4146 units |
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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.