Vygon
neosump Ø2.5mm - 8Fr - 600mm - Gastric Aspirator - Contents : Dual flow gastric aspiration tube & Sampling trap cap 35ml
25manufacturers in China registered for this device type
229catalogue numbers in this listing
4510(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 | Vygon Corp., United States |
|---|---|
| FDA product code | KNT |
| Device type | Tubes, Gastrointestinal (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5980 |
| 510(k) | K060944 |
| Record published | 2019-09-26 |
| Record revised | 2021-10-29 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 5 to 40 °C |
| Packaging | Box of 50, box of 10, case of 18, pack of 10, case of 12, pack of 25 |
| Distribution end date | 2020-10-09 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2394.14 | In distribution | |
| 2391.16 | In distribution | |
| 1340.16 | In distribution | |
| 310.12 | In distribution | |
| 391.18 | In distribution | |
| 2331.062G | In distribution | |
| 1015.032M | In distribution | |
| 2316.16 | In distribution | |
| 1022.052 | In distribution | |
| 1022.012 | In distribution | |
| 1310.08 | In distribution | |
| 1015.352M-NS | In distribution | |
| 2394.16 | In distribution | |
| 1310.05 | In distribution | |
| 2394.10 | In distribution | |
| 1011.052 | In distribution | |
| 1311.05 | In distribution | |
| 1340.14 | In distribution | |
| 310.08 | In distribution | |
| 1310.04 | In distribution | |
| 1015.602M | In distribution | |
| 310.08 | In distribution | |
| 312.08 | In distribution | |
| 1310.06 | In distribution | |
| 1015.122M | In distribution | |
| 312.07 | In distribution | |
| 2395.09 | In distribution | |
| 1311.04 | In distribution | |
| 311.05 | In distribution | |
| 2331.082G | In distribution | |
| 2395.06 | In distribution | |
| 5382.06 | In distribution | |
| 1340.06 | In distribution | |
| 2331.042G | In distribution | |
| 5382.10 | In distribution | |
| 310.04 | In distribution | |
| 1011.012 | In distribution | |
| 2331.102 | In distribution | |
| 1022.002 | In distribution | |
| 310.10 | In distribution | |
| 312.04 | In distribution | |
| 1015.352M | In distribution | |
| 5382.06 | In distribution | |
| 368.42R | In distribution | |
| 340.14 | In distribution | |
| 391.12 | In distribution | |
| 1015.014 | In distribution | |
| 1011.022 | In distribution | |
| 311.06 | In distribution | |
| 340.06 | In distribution | |
| 1015.202M | In distribution | |
| 391.21 | In distribution | |
| 340.10 | In distribution | |
| 817.057 | In distribution | |
| 5557.550 | In distribution | |
| 310.06 | In distribution | |
| 1310.06 | In distribution | |
| 5382.08 | In distribution | |
| 390.10 | In distribution | |
| 2331.052G | In distribution | |
| 2316.12 | In distribution | |
| 391.10 | In distribution | |
| 1340.18 | In distribution | |
| 311.05 | In distribution | |
| 391.14 | In distribution | |
| 391.08 | In distribution | |
| 310.05 | In distribution | |
| 1340.12 | In distribution | |
| 2332.062G | In distribution | |
| 391.16 | In distribution | |
| 1340.10 | In distribution | |
| 1340.06 | In distribution | |
| 340.21 | In distribution | |
| 340.21 | In distribution | |
| 1311.08 | In distribution | |
| 1015.352M | In distribution | |
| 1311.08 | In distribution | |
| 5382.08 | In distribution | |
| 391.16 | In distribution | |
| 1015.602M-NS | In distribution | |
| 2394.12 | In distribution | |
| 1015.062M | In distribution | |
| 1015.122M | In distribution | |
| 340.08 | In distribution | |
| 1311.05 | In distribution | |
| 340.08 | In distribution | |
| 391.21 | In distribution | |
| 2395.05 | In distribution | |
| 1340.10 | In distribution | |
| 1015.062M | In distribution | |
| 310.06 | In distribution | |
| 312.10 | In distribution | |
| 310.09 | In distribution | |
| 312.06 | In distribution | |
| 340.12 | In distribution | |
| 391.12 | In distribution | |
| 1022.102 | In distribution | |
| 817.157 | In distribution | |
| 2332.102 | In distribution | |
| 340.12 | In distribution | |
| 2395.062G | In distribution | |
| 340.18 | In distribution | |
| 311.06 | In distribution | |
| 1011.002 | In distribution | |
| 340.06 | In distribution | |
| 1310.08 | In distribution | |
| 340.10 | In distribution | |
| 311.08 | In distribution | |
| 391.06 | In distribution | |
| 2395.082 | In distribution | |
| 2332.042G | In distribution | |
| 312.09 | In distribution | |
| 363.122 | In distribution | |
| 311.04 | In distribution | |
| 828.66 | In distribution | |
| 1015.032M | In distribution | |
| 2391.08 | In distribution | |
| 1310.04 | In distribution | |
| 340.08 | In distribution | |
| 312.12 | In distribution | |
| 310.09 | In distribution | |
| 311.10 | In distribution | |
| 1022.022 | In distribution | |
| 391.08 | In distribution | |
| 1015.602M | In distribution | |
| 1340.08 | In distribution | |
| 310.07 | In distribution | |
| 1311.06 | In distribution | |
| 340.16 | In distribution | |
| 1362.1221 | In distribution | |
| 1310.05 | In distribution | |
| 391.10 | In distribution | |
| 340.16 | In distribution | |
| 312.12 | In distribution | |
| 828.88 | In distribution | |
| 1015.122M-NS | In distribution | |
| 312.10 | In distribution | |
| 5382.10 | In distribution | |
| 1311.08 | In distribution | |
| 2332.082G | In distribution | |
| 2395.082G | In distribution | |
| 310.12 | In distribution | |
| 1015.024 | In distribution | |
| 1015.202M | In distribution | |
| 390.16 | In distribution | |
| 312.10 | Withdrawn | |
| 310.10 | Withdrawn | |
| 312.06 | Withdrawn | |
| 1340.10 | Withdrawn | |
| 391.16 | Withdrawn | |
| 391.21 | Withdrawn | |
| 310.06 | Withdrawn | |
| 1311.04 | Withdrawn | |
| 1311.06 | Withdrawn | |
| 391.14 | Withdrawn | |
| 340.14 | Withdrawn | |
| 310.09 | Withdrawn | |
| 310.10 | Withdrawn | |
| 311.08 | Withdrawn | |
| 340.18 | Withdrawn | |
| 2395.09 | Withdrawn | |
| 312.08 | Withdrawn | |
| 340.14 | Withdrawn | |
| 1310.06 | Withdrawn | |
| 391.06 | Withdrawn | |
| 312.08 | Withdrawn | |
| 391.08 | Withdrawn | |
| 390.10 | Withdrawn | |
| 311.04 | Withdrawn | |
| 391.06 | Withdrawn | |
| 340.06 | Withdrawn | |
| 1340.06 | Withdrawn | |
| 311.06 | Withdrawn | |
| 310.10 | Withdrawn | |
| 340.08 | Withdrawn | |
| 391.14 | Withdrawn | |
| 310.06 | Withdrawn | |
| 310.05 | Withdrawn | |
| 1310.04 | Withdrawn | |
| 2394.12 | Withdrawn | |
| 340.18 | Withdrawn | |
| 311.10 | Withdrawn | |
| 311.04 | Withdrawn | |
| 1340.12 | Withdrawn | |
| 391.10 | Withdrawn | |
| 2394.14 | Withdrawn | |
| 1340.18 | Withdrawn | |
| 310.08 | Withdrawn | |
| 1340.16 | Withdrawn | |
| 311.10 | Withdrawn | |
| 391.18 | Withdrawn | |
| 391.18 | Withdrawn | |
| 311.08 | Withdrawn | |
| 2395.05 | Withdrawn | |
| 310.05 | Withdrawn | |
| 310.04 | Withdrawn | |
| 310.04 | Withdrawn | |
| 391.12 | Withdrawn | |
| 340.06 | Withdrawn | |
| 2394.10 | Withdrawn | |
| 5382.06 | Withdrawn | |
| 310.12 | Withdrawn | |
| 310.08 | Withdrawn | |
| 340.10 | Withdrawn | |
| 340.16 | Withdrawn | |
| 312.06 | Withdrawn | |
| 1340.08 | Withdrawn | |
| 1340.14 | Withdrawn | |
| 1340.18 | Withdrawn | |
| 340.14 | Withdrawn | |
| 340.18 | Withdrawn | |
| 310.07 | Withdrawn | |
| 340.16 | Withdrawn | |
| 1340.14 | Withdrawn | |
| 2394.16 | Withdrawn | |
| 310.05 | Withdrawn | |
| 1310.08 | Withdrawn | |
| 390.10 | Withdrawn | |
| 312.04 | Withdrawn | |
| 340.21 | Withdrawn | |
| 5382.08 | Withdrawn | |
| 310.07 | Withdrawn | |
| 310.07 | Withdrawn | |
| 1311.05 | Withdrawn | |
| 1340.16 | Withdrawn | |
| 340.12 | Withdrawn | |
| 1310.05 | Withdrawn | |
| 2395.06 | Withdrawn | |
| 312.12 | 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 |
| NeoDevices, Inc. | Neodevices Inc | 123 |
| Corflo cuBBy Lpgd | Corpak Medsystems | 98 |
| Kangaroo | Cardinal Health 200, LLC | 98 |
| MiniACE | Applied Medical Technology, Inc. | 93 |
Showing 12 of 457. All products under Tubes, Gastrointestinal (And Accessories)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K991918 | 1999-10-29 |
| K974806 | 1998-03-23 |
| K925854 | 1994-05-02 |
| K860285 | 1986-02-11 |
Recalls Naming This Product
2 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 |
|---|---|---|---|---|---|---|---|
| Vygon MFG | 510(k) number | 2010-01-29 | Not classified | Labeling Change Control | Mislabeled feeding syringes : 6 ml syringe mislabeled as 5 ml. | 29,700 eaches | 2010-09-23 |
| Vygon MFG | 510(k) number | 2010-01-29 | Not classified | Labeling Change Control | Mislabeled feeding syringes : 12 ml syringe mislabeled as 10 ml. | 99,900 eaches | 2010-09-23 |
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.