Entake
Dual Port Feeding Adaptor
25manufacturers in China registered for this device type
34catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (17), Zhejiang (4), Guangdong (2). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Jiangsu JianYu Health Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 35 |
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Conod Medical Shuyang Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 22 |
| Jiangsu Caina Medical Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 20 |
| Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 18 |
| Mcreat ( Guangzhou ) BIO-Tech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 14 |
| Primecare Medical (Huzhou) Co., Ltd. | Hu Zhou | Zhejiang | Contract manufacturer | 9 |
| Yangzhou Xingwei Medical Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 5 |
| Tessy Plastics Shanghai Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 4 |
| Flexan (Suzhou) Precision Rubber Products Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 1 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
Showing 12 of 25. All 25 manufacturers in China registered for Tubes, Gastrointestinal (And Accessories)
Record
| Listed by | ConMed Corporation, United States |
|---|---|
| FDA product code | KNT |
| Device type | Tubes, Gastrointestinal (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5980 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K061021 |
| Record published | 2016-09-24 |
| Record revised | 2023-03-21 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 5, box of 10, unit of 10 |
| Sizes | Catheter gauge 14 to 28 Fr |
| Distribution end date | 2023-09-07 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| FESG1400 | Catheter Gauge 14 Fr | Withdrawn | |
| FESG1800 | Catheter Gauge 18 Fr | Withdrawn | |
| FESG14ND | Catheter Gauge 14 Fr | Withdrawn | |
| FEDP1820 | 18/20 French Catheter Gauge | 5 | Withdrawn |
| FESP2000 | Catheter Gauge 20 Fr | Withdrawn | |
| FEXP2000 | Catheter Gauge 20 Fr | Withdrawn | |
| FESP1400 | Catheter Gauge 14 Fr | Withdrawn | |
| FEXP18ND | Catheter Gauge 18 Fr | Withdrawn | |
| FEAC1400 | 10 | Withdrawn | |
| FEXG2400 | Catheter Gauge 24 Fr | Withdrawn | |
| FESP14ND | Catheter Gauge 14 Fr | Withdrawn | |
| FEXP2400 | Catheter Gauge 24 Fr | Withdrawn | |
| FESP18ND | Catheter Gauge 28 Fr | Withdrawn | |
| FEXG24ND | Catheter Gauge 24 Fr | Withdrawn | |
| FESP1800 | Catheter Gauge 18 Fr | Withdrawn | |
| FESP2400 | Catheter Gauge 24 Fr | Withdrawn | |
| FESG20ND | Catheter Gauge 20 Fr | Withdrawn | |
| FEXG20ND | Catheter Gauge 20 Fr | Withdrawn | |
| FESG2400 | Catheter Gauge 24 Fr | Withdrawn | |
| FESG24ND | Catheter Gauge 24 Fr | Withdrawn | |
| FEDP2400 | Catheter Gauge 24 Fr | 5 | Withdrawn |
| FESG2000 | Catheter Gauge 20 Fr | Withdrawn | |
| FEXP1800 | Catheter Gauge 18 Fr | Withdrawn | |
| FEXP14ND | Catheter Gauge 14 Fr | Withdrawn | |
| FESP20ND | Catheter Gauge 20 Fr | Withdrawn | |
| FEXP20ND | Catheter Gauge 20 Fr | Withdrawn | |
| FEXP24ND | Catheter Gauge 24 Fr | Withdrawn | |
| FEXG1800 | Catheter Gauge 18 Fr | Withdrawn | |
| FESP24ND | Catheter Gauge 24 Fr | Withdrawn | |
| FEXG1400 | Catheter Gauge 14 Fr | Withdrawn | |
| FEDP1400 | Catheter Gauge 14 Fr | 5 | Withdrawn |
| FEAC2000 | Catheter Gauge 20 Fr | 10 | Withdrawn |
| FEXP1400 | Catheter Gauge 14 Fr | Withdrawn | |
| FEXG2000 | Catheter Gauge 20 Fr | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Avanos | Avanos Medical, Inc. | 1,169 |
| Halyard | Avanos Medical, Inc. | 1,004 |
| G-Jet® Transgastric-Jejunal Feeding Device | Applied Medical Technology, Inc. | 376 |
| MiniONE Balloon Button | Applied Medical Technology, Inc. | 373 |
| Mini ONE® Balloon Button | Applied Medical Technology, Inc. | 336 |
| Kangaroo | Cardinal Health | 326 |
| NutraGlide Nasal Feeding Tube | Applied Medical Technology, Inc. | 279 |
| AMT Mini™ Balloon Button | Applied Medical Technology, Inc. | 231 |
| Vygon | Vygon Corp. | 229 |
| NeoDevices, Inc. | Neodevices Inc | 123 |
| Corflo cuBBy Lpgd | Corpak Medsystems | 98 |
| Kangaroo | Cardinal Health 200, LLC | 98 |
Showing 12 of 457. All products under Tubes, Gastrointestinal (And Accessories)
Recalls Naming This Product
28 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 |
|---|---|---|---|---|---|---|---|
| Bard Access Systems, Inc. | 510(k) number | 2008-12-04 | Not classified | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal duri | 177,614 units | 2011-11-09 |
| Bard Access Systems, Inc. | 510(k) number | 2008-12-04 | Not classified | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal duri | 177,614 units | 2011-11-09 |
| Bard Access Systems, Inc. | 510(k) number | 2008-12-04 | Not classified | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal duri | 177,614 units | 2011-11-09 |
| Bard Access Systems, Inc. | 510(k) number | 2008-12-04 | Not classified | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal duri | 177,614 units | 2011-11-09 |
| Bard Access Systems, Inc. | 510(k) number | 2008-12-04 | Not classified | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal duri | 177,614 units | 2011-11-09 |
| Bard Access Systems, Inc. | 510(k) number | 2008-12-04 | Not classified | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal duri | 177,614 units | 2011-11-09 |
| Bard Access Systems, Inc. | 510(k) number | 2008-12-04 | Not classified | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal duri | 177,614 units | 2011-11-09 |
| Bard Access Systems, Inc. | 510(k) number | 2008-12-04 | Not classified | Nonconforming Material/Component | The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal during use, necessitating retriev | 177,614 units | 2011-11-09 |
| Bard Access Systems, Inc. | 510(k) number | 2008-12-04 | Not classified | Nonconforming Material/Component | The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal during use, necessitating retriev | 177,614 units | 2011-11-09 |
| Bard Access Systems, Inc. | 510(k) number | 2008-12-04 | Not classified | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal duri | 177,614 units | 2011-11-09 |
| Bard Access Systems, Inc. | 510(k) number | 2008-12-04 | Not classified | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal duri | 177,614 units | 2011-11-09 |
| Bard Access Systems, Inc. | 510(k) number | 2008-12-04 | Not classified | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal duri | 177,614 units | 2011-11-09 |
| Bard Access Systems, Inc. | 510(k) number | 2008-12-04 | Not classified | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal duri | 177,614 units | 2011-11-09 |
| Bard Access Systems, Inc. | 510(k) number | 2008-12-04 | Not classified | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal duri | 177,614 units | 2011-11-09 |
| Bard Access Systems, Inc. | 510(k) number | 2008-12-04 | Not classified | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal duri | 177,614 units | 2011-11-09 |
| Bard Access Systems, Inc. | 510(k) number | 2008-12-04 | Not classified | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal duri | 177,614 units | 2011-11-09 |
| Bard Access Systems, Inc. | 510(k) number | 2008-12-04 | Not classified | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal duri | 177,614 units | 2011-11-09 |
| Bard Access Systems, Inc. | 510(k) number | 2008-12-04 | Not classified | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal duri | 177,614 units | 2011-11-09 |
| Bard Access Systems, Inc. | 510(k) number | 2008-12-04 | Not classified | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal duri | 177,614 units | 2011-11-09 |
| Bard Access Systems, Inc. | 510(k) number | 2008-12-04 | Not classified | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal duri | 177,614 units | 2011-11-09 |
| Bard Access Systems, Inc. | 510(k) number | 2008-12-04 | Not classified | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal duri | 177,614 units | 2011-11-09 |
| Bard Access Systems, Inc. | 510(k) number | 2008-12-04 | Not classified | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal duri | 177,614 units | 2011-11-09 |
| Bard Access Systems, Inc. | 510(k) number | 2008-12-04 | Not classified | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal duri | 177,614 units | 2011-11-09 |
| Bard Access Systems, Inc. | 510(k) number | 2008-12-04 | Not classified | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal duri | 177,614 units | 2011-11-09 |
| Bard Access Systems, Inc. | 510(k) number | 2008-12-04 | Not classified | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal duri | 177,614 units | 2011-11-09 |
| Bard Access Systems, Inc. | 510(k) number | 2008-12-04 | Not classified | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal duri | 177,614 units | 2011-11-09 |
| Bard Access Systems, Inc. | 510(k) number | 2008-12-04 | Not classified | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal duri | 177,614 units | 2011-11-09 |
| Bard Access Systems, Inc. | 510(k) number | 2008-12-04 | Not classified | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal duri | 177,614 units | 2011-11-09 |
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.