Teleflex
Teleflex Isis™ Suction Accessory Pack, Sterile
9manufacturers in China registered for this device type
19catalogue 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) | K091761 |
| Record published | 2015-10-16 |
| Record revised | 2025-03-12 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 32 to 122 °F |
| Packaging | Case of 10, box of 10, case of 8, box of 5 |
| Sizes | Length 15 to 255 mm; width 15 mm; height 17 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN044811 | Tracheal Tube, Cuffed with Subglottic Secretion Suction Port | In distribution |
| IPN044826 | Tracheal Tube, Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet | In distribution |
| IPN044918 | Length 255 mm | In distribution |
| IPN044830 | Length 15 mm | In distribution |
| IPN048976 | In distribution | |
| IPN048977 | In distribution | |
| IPN044809 | Tracheal Tube, Cuffed with Subglottic Secretion Suction Port | In distribution |
| IPN044829 | Length 15 mm | In distribution |
| IPN044831 | Tracheal Tube, Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet | In distribution |
| IPN048975 | In distribution | |
| IPN044815 | Length 15 mm | In distribution |
| IPN048979 | In distribution | |
| IPN044813 | Tracheal Tube, Cuffed with Subglottic Secretion Suction Port | In distribution |
| IPN044825 | Tracheal Tube, Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet | In distribution |
| IPN044810 | Length 15 mm | In distribution |
| IPN044812 | Tracheal Tube, Cuffed with Subglottic Secretion Suction Port | In distribution |
| IPN044827 | Length 15 mm | In distribution |
| IPN044814 | Tracheal Tube, Cuffed with Subglottic Secretion Suction Port | In distribution |
| IPN044828 | Tracheal Tube, Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rusch | Teleflex Medical LLC | 301 |
| 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 |
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
15 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 |
|---|---|---|---|---|---|---|---|
| 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 | 2014-01-06 | Class I | Other | The tracheal tube can kink during patient use. | 190,871 each (148, 275 US) | 2016-06-17 |
| Teleflex Medical LLC | 510(k) number | 2014-01-06 | Class I | Other | The tracheal tube can kink during patient use. | 190,871 each (148, 275 US) | 2016-06-17 |
| Teleflex Medical LLC | 510(k) number | 2014-01-06 | Class I | Other | The tracheal tube can kink during patient use. | 190,871 each (148, 275 US) | 2016-06-17 |
| Teleflex Medical LLC | 510(k) number | 2014-01-06 | Class I | Other | The tracheal tube can kink during patient use. | 190,871 each (148, 275 US) | 2016-06-17 |
| Teleflex Medical LLC | 510(k) number | 2014-01-06 | Class I | Other | The tracheal tube can kink during patient use. | 190,871 each (148, 275 US) | 2016-06-17 |
| Teleflex Medical LLC | 510(k) number | 2014-01-06 | Class I | Other | The tracheal tube can kink during patient use. | 190,871 each (148, 275 US) | 2016-06-17 |
| Teleflex Medical LLC | 510(k) number | 2014-01-06 | Class I | Other | The tracheal tube can kink during patient use. | 190,871 each (148, 275 US) | 2016-06-17 |
| Teleflex Medical LLC | 510(k) number | 2014-01-06 | Class I | Other | The tracheal tube can kink during patient use. | 190,871 each (148, 275 US) | 2016-06-17 |
| Teleflex Medical LLC | 510(k) number | 2014-01-06 | Class I | Other | The tracheal tube can kink during patient use. | 190,871 each (148, 275 US) | 2016-06-17 |
| Teleflex Medical LLC | 510(k) number | 2014-01-06 | Class I | Other | The tracheal tube can kink during patient use. | 190,871 each (148, 275 US) | 2016-06-17 |
| Teleflex Medical LLC | 510(k) number | 2014-01-06 | Class I | Other | The tracheal tube can kink during patient use. | 190,871 each (148, 275 US) | 2016-06-17 |
| Teleflex Medical LLC | 510(k) number | 2014-01-06 | Class I | Other | The tracheal tube can kink during patient use. | 190,871 each (148, 275 US) | 2016-06-17 |
| Teleflex Medical LLC | 510(k) number | 2014-01-06 | Class I | Other | The tracheal tube can kink during patient use. | 190,871 each (148, 275 US) | 2016-06-17 |
| Teleflex Medical LLC | 510(k) number | 2014-01-06 | Class I | Other | The tracheal tube can kink during patient use. | 190,871 each (148, 275 US) | 2016-06-17 |
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.