Medela
Polyurethane Enteral Feeding Tube - TwistLok - 16in by 6.5 French
25manufacturers in China registered for this device type
72catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Footprint Medical Inc., United States |
|---|---|
| FDA product code | KNT |
| Device type | Tubes, Gastrointestinal (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5980 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K102548 |
| Record published | 2017-11-16 |
| Record revised | 2018-07-06 (version 3) |
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 |
| Packaging | Carton of 10 |
| Sizes | Catheter gauge 4 to 10 Fr; length 16 to 42 in; length 40 to 90 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ENPU2050 | Length 20 in | In distribution |
| ENFPU1640LD | Length 16 in | In distribution |
| ENSI9065 | Catheter Gauge 6.5 Fr | In distribution |
| ENFPU2050LD | Length 20 in | In distribution |
| ENFSI9065 | Length 90 cm | In distribution |
| ENPU2040 | Length 20 in | In distribution |
| ENFPU1665LD | Length 16 in | In distribution |
| ENPU-20-40 | Catheter Gauge 4 Fr | In distribution |
| ENPU4280 | Length 42 in | In distribution |
| ENFSI6065 | Length 60 cm | In distribution |
| ENSI6050 | Catheter Gauge 5 Fr | In distribution |
| ENFSI4065 | Length 40 cm | In distribution |
| ENPU-16-40 | Catheter Gauge 4 Fr | In distribution |
| ENPU1665 | Length 16 in | In distribution |
| ENSI6080 | Catheter Gauge 8 Fr | In distribution |
| ENPU42100 | Length 42 in | In distribution |
| ENFSI9050 | Length 90 cm | In distribution |
| ENFSI6080LD | Catheter Gauge 8 Fr | In distribution |
| ENPU-36-50 | Catheter Gauge 5 Fr | In distribution |
| ENSI-60-65 | Length 60 cm | In distribution |
| ENPU-42-80 | Catheter Gauge 8 Fr | In distribution |
| ENSI6065 | Catheter Gauge 6.5 Fr | In distribution |
| ENSI4080 | Catheter Gauge 8 Fr | In distribution |
| ENFPU3665LD | Length 36 in | In distribution |
| ENPU3650 | Length 36 in | In distribution |
| ENSI-60-80 | Length 60 cm | In distribution |
| ENFSI4050LD | Catheter Gauge 5 Fr | In distribution |
| ENFSI9080 | Length 90 cm | In distribution |
| ENPU-16-65 | Catheter Gauge 6.5 Fr | In distribution |
| ENPU-36-65 | Catheter Gauge 6.5 Fr | In distribution |
| ENPU-20-65 | Catheter Gauge 6.5 Fr | In distribution |
| ENFPU1650LD | Length 16 in | In distribution |
| ENPU-20-50 | Catheter Gauge 5 Fr | In distribution |
| ENPU2080 | Length 20 in | In distribution |
| ENSI9050 | Catheter Gauge 5 Fr | In distribution |
| ENFPU2040LD | Length 20 in | In distribution |
| ENSI4065 | Catheter Gauge 6.5 Fr | In distribution |
| ENSI4050 | Catheter Gauge 5 Fr | In distribution |
| ENSI9080 | Catheter Gauge 8 Fr | In distribution |
| ENFPU1680LD | Length 16 in | In distribution |
| ENFPU2065LD | Length 20 in | In distribution |
| ENFSI4080LD | Catheter Gauge 8 Fr | In distribution |
| ENFSI6050 | Length 60 cm | In distribution |
| ENPU3665 | Length 36 in | In distribution |
| ENFSI6065LD | Catheter Gauge 6.5 Fr | In distribution |
| ENFSI4050 | Length 40 cm | In distribution |
| ENPU1650 | Length 16 in | In distribution |
| ENSI-40-65 | Length 40 cm | In distribution |
| ENPU-42-100 | Catheter Gauge 10 Fr | In distribution |
| ENSI-90-80 | Length 90 cm | In distribution |
| ENFSI9050LD | Catheter Gauge 5 Fr | In distribution |
| ENSI-90-65 | Length 90 cm | In distribution |
| ENFPU2080LD | Length 20 in | In distribution |
| ENFPU42100LD | Length 42 in | In distribution |
| ENPU2065 | Length 20 in | In distribution |
| ENFPU4280LD | Length 42 in | In distribution |
| ENPU-16-80 | Catheter Gauge 8 Fr | In distribution |
| ENSI-60-50 | Length 60 cm | In distribution |
| ENFSI9080LD | Catheter Gauge 8 Fr | In distribution |
| ENFSI9065LD | Catheter Gauge 6.5 Fr | In distribution |
| ENSI-40-50 | Length 40 cm | In distribution |
| ENFSI4065LD | Catheter Gauge 6.5 Fr | In distribution |
| ENFSI6080 | Length 60 cm | In distribution |
| ENPU-20-80 | Catheter Gauge 8 Fr | In distribution |
| ENFSI4080 | Length 40 cm | In distribution |
| ENFPU3650LD | Length 36 in | In distribution |
| ENSI-90-50 | Length 90 cm | In distribution |
| ENPU1640 | Length 16 in | In distribution |
| ENSI-40-80 | Length 40 cm | In distribution |
| ENPU1680 | Length 16 in | In distribution |
| ENFSI6050LD | Catheter Gauge 5 Fr | In distribution |
| ENPU-16-50 | Catheter Gauge 5 Fr | In distribution |
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)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K102548 | 2010-11-26 |
| K090559 | 2009-05-04 |
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.