Vygon
nutrisafe2 extension tubes with clamp - Ø 1.5 x 2.5 mm - L. 100cm - 1.86 mL [1.47 / 2.03]
3manufacturers in China registered for this device type
236catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (1), Zhejiang (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| ShanDong WeiGao Group Medical Polymer Co., Ltd. | Weihai | Shandong | Contract manufacturer | 3 |
| VR Medical Technology Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 13 |
| Ningbo Tianyi Medical Appliance Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 11 |
Record
| Listed by | Vygon Corp., United States |
|---|---|
| FDA product code | FPD |
| Device type | Tube, Feeding |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5980 |
| Record published | 2016-09-16 |
| Record revised | 2021-10-29 (version 8) |
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, manufacturing date |
| Storage | Storage environment temperature 5 to 40 °C |
| Packaging | Peel pack of 25, pack of 25, box of 25, peel pack of 12, peel pack of 6, pack of 24 |
| Distribution end date | 2020-06-02 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1015.002 | 100 | In distribution | |
| 362.087 | In distribution | ||
| 1362.087 | In distribution | ||
| 1364.042 | In distribution | ||
| 368.1071 | In distribution | ||
| 366.107 | In distribution | ||
| 1363.1221 | In distribution | ||
| 1361.067 | In distribution | ||
| 817.152 | In distribution | ||
| 364.067 | In distribution | ||
| 1363.057 | In distribution | ||
| 368.22 | In distribution | ||
| 363.052 | In distribution | ||
| 1015.022 | 100 | In distribution | |
| 1364.067 | In distribution | ||
| 1015.1041 | In distribution | ||
| 362.082 | In distribution | ||
| 1364.082 | In distribution | ||
| 366.127 | In distribution | ||
| 361.052 | In distribution | ||
| 362.052 | In distribution | ||
| 361.042 | In distribution | ||
| 1362.1621 | In distribution | ||
| 828.66SRC | In distribution | ||
| 363.102 | In distribution | ||
| 1362.142 | In distribution | ||
| 1361.047 | In distribution | ||
| 39.29.01 | In distribution | ||
| 1015.102 | 100 | In distribution | |
| 362.182 | In distribution | ||
| 363.062 | In distribution | ||
| 1363.082 | In distribution | ||
| 1362.042 | In distribution | ||
| 1015.202 | 50 | In distribution | |
| 1364.087 | In distribution | ||
| 362.062 | In distribution | ||
| 368.02 | In distribution | ||
| 1362.057 | In distribution | ||
| 362.067 | In distribution | ||
| 363.062 | In distribution | ||
| 36.45.20 | In distribution | ||
| 1363.087 | In distribution | ||
| 1364.052 | In distribution | ||
| 366.087 | In distribution | ||
| 339.0172 | In distribution | ||
| 364.062 | In distribution | ||
| 1364.062 | In distribution | ||
| 1361.042 | In distribution | ||
| 1366.1471 | In distribution | ||
| 362.122 | In distribution | ||
| 1361.082 | In distribution | ||
| 1362.182 | In distribution | ||
| 1366.087 | In distribution | ||
| 1362.162 | In distribution | ||
| 1366.1271 | In distribution | ||
| 1364.047 | In distribution | ||
| 5571.303 | In distribution | ||
| 1362.1072 | In distribution | ||
| 1363.0621 | In distribution | ||
| 5557.450 | In distribution | ||
| 828.01 | In distribution | ||
| 362.102 | In distribution | ||
| 1015.6041 | In distribution | ||
| 1366.1072 | In distribution | ||
| 362.107 | In distribution | ||
| 1362.1421 | In distribution | ||
| 364.087 | In distribution | ||
| 363.087 | In distribution | ||
| 1363.1021 | In distribution | ||
| 1362.142 | In distribution | ||
| 361.082 | In distribution | ||
| 362.162 | In distribution | ||
| 362.047 | In distribution | ||
| 362.127 | In distribution | ||
| 361.102 | In distribution | ||
| 1361.107 | In distribution | ||
| 821.012 | In distribution | ||
| 1366.1071 | In distribution | ||
| 1362.147 | In distribution | ||
| 1363.1421 | In distribution | ||
| 1363.062 | In distribution | ||
| 362.062 | In distribution | ||
| 361.087 | In distribution | ||
| 1362.167 | In distribution | ||
| 1363.0821 | In distribution | ||
| 1364.057 | In distribution | ||
| 362.102 | In distribution | ||
| 362.142 | In distribution | ||
| 364.062 | In distribution | ||
| 368.42 | In distribution | ||
| 821.21 | In distribution | ||
| 364.057 | In distribution | ||
| 1366.127 | In distribution | ||
| 1362.187 | In distribution | ||
| 1363.042 | In distribution | ||
| 364.047 | In distribution | ||
| 1362.182 | In distribution | ||
| 368.1021 | In distribution | ||
| 363.102 | In distribution | ||
| 1366.0671 | In distribution | ||
| 1362.1021 | In distribution | ||
| 1361.087 | In distribution | ||
| 1362.0671 | In distribution | ||
| 1022.102 | 50 | In distribution | |
| 2316.10 | In distribution | ||
| 1363.107 | In distribution | ||
| 368.102 | In distribution | ||
| 369.152 | In distribution | ||
| 1361.102 | In distribution | ||
| 362.057 | In distribution | ||
| 1015.012 | 100 | In distribution | |
| 828.08 | In distribution | ||
| 1362.1821 | In distribution | ||
| 363.107 | In distribution | ||
| 362.142 | In distribution | ||
| 817.052 | In distribution | ||
| 1362.0621 | In distribution | ||
| 1015.352 | 50 | In distribution | |
| 361.057 | In distribution | ||
| 1363.1621 | In distribution | ||
| 363.052 | In distribution | ||
| 362.147 | In distribution | ||
| 361.042 | In distribution | ||
| 363.087 | In distribution | ||
| 1022.012 | 50 | In distribution | |
| 368.107 | In distribution | ||
| 818.62 | In distribution | ||
| 368.152 | In distribution | ||
| 817.202 | In distribution | ||
| 364.082 | In distribution | ||
| 1022.052 | 50 | In distribution | |
| 1362.0821 | In distribution | ||
| 1015.052 | 100 | In distribution | |
| 1362.1271 | In distribution | ||
| 821.022 | In distribution | ||
| 363.067 | In distribution | ||
| 1362.1221 | In distribution | ||
| 1362.127 | In distribution | ||
| 368.12 | In distribution | ||
| 1363.052 | In distribution | ||
| 1363.122 | In distribution | ||
| 1015.054 | In distribution | ||
| 363.042 | In distribution | ||
| 829.01 | In distribution | ||
| 363.082 | In distribution | ||
| 2396.14 | In distribution | ||
| 1366.0872 | In distribution | ||
| 1015.212 | 50 | In distribution | |
| 363.127 | In distribution | ||
| 366.107 | In distribution | ||
| 1363.127 | In distribution | ||
| 362.187 | In distribution | ||
| 1361.057 | In distribution | ||
| 368.32 | In distribution | ||
| 1366.1671 | In distribution | ||
| 363.127 | In distribution | ||
| 1362.1071 | In distribution | ||
| 368.1521 | In distribution | ||
| 1362.062 | In distribution | ||
| 828.77 | In distribution | ||
| 1363.0821 | In distribution | ||
| 1363.102 | In distribution | ||
| 1366.1272 | In distribution | ||
| 362.167 | In distribution | ||
| 361.052 | In distribution | ||
| 5249.721 | In distribution | ||
| 369.152 | In distribution | ||
| 81363.062F | In distribution | ||
| 1362.052 | In distribution | ||
| 1363.0621 | In distribution | ||
| 364.052 | In distribution | ||
| 364.042 | In distribution | ||
| 1022.022 | 50 | In distribution | |
| 1362.122 | In distribution | ||
| 366.187 | In distribution | ||
| 362.122 | In distribution | ||
| 1362.102 | In distribution | ||
| 1362.0821 | In distribution | ||
| 1366.107 | In distribution | ||
| 368.157 | In distribution | ||
| 1363.1621 | In distribution | ||
| 368.032 | In distribution | ||
| 366.167 | In distribution | ||
| 361.047 | In distribution | ||
| 1361.062 | In distribution | ||
| 363.082 | In distribution | ||
| 1366.0871 | In distribution | ||
| 1363.047 | In distribution | ||
| 1361.052 | In distribution | ||
| 1363.1821 | In distribution | ||
| 366.147 | In distribution | ||
| 368.47 | In distribution | ||
| 1362.107 | In distribution | ||
| 368.72 | In distribution | ||
| 1363.1421 | In distribution | ||
| 1362.1272 | In distribution | ||
| 1363.067 | In distribution | ||
| 5802.01 | In distribution | ||
| 361.062 | In distribution | ||
| 361.067 | In distribution | ||
| 363.122 | In distribution | ||
| 818.22 | In distribution | ||
| 1362.067 | In distribution | ||
| 1362.1021 | In distribution | ||
| 361.107 | In distribution | ||
| 1015.602 | 25 | In distribution | |
| 368.1571 | In distribution | ||
| 1363.122 | In distribution | ||
| 1362.047 | In distribution | ||
| 362.042 | In distribution | ||
| 1362.082 | In distribution | ||
| 828.99 | In distribution | ||
| 1363.082 | Withdrawn | ||
| 1362.102 | Withdrawn | ||
| 363.042 | Withdrawn | ||
| 362.162 | Withdrawn | ||
| 361.062 | Withdrawn | ||
| 1362.082 | Withdrawn | ||
| 361.102 | Withdrawn | ||
| 368.102 | Withdrawn | ||
| 364.082 | Withdrawn | ||
| 364.042 | Withdrawn | ||
| 1363.102 | Withdrawn | ||
| 1361.082 | Withdrawn | ||
| 1361.102 | Withdrawn | ||
| 362.082 | Withdrawn | ||
| 368.152 | Withdrawn | ||
| 361.082 | Withdrawn | ||
| 1364.082 | Withdrawn | ||
| 1362.122 | Withdrawn | ||
| 368.22 | Withdrawn | ||
| 368.1521 | Withdrawn | ||
| 368.1021 | Withdrawn | ||
| 368.032 | Withdrawn | ||
| 364.052 | Withdrawn | ||
| 362.052 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ameritus | Kentec Medical, LLC | 83 |
| Avanos | Avanos Medical, Inc. | 51 |
| Halyard | Avanos Medical, Inc. | 50 |
| Ameritus ENFit | Kentec Medical, LLC | 38 |
| MED-RX | Canadian Hospital Specialties Ltd. | 28 |
| DeRoyal | Deroyal Industries, Inc. | 20 |
| ENFit SIL Feeding Tube | Avanos Medical, Inc. | 18 |
| NeoConnect Enteral Feeding Tube | Neomed Co., Ltd. | 18 |
| TubeClear | Actuated Medical, Inc. | 14 |
| Corflo Ultra Lite NG | Corpak Medsystems | 13 |
| Aquarius | Degania Silicone, Ltd. | 11 |
| NeoMed Enteral Feeding Tube | Neomed Co., Ltd. | 11 |
Showing 12 of 33. All products under Tube, Feeding
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K121105 | 2012-12-18 |
| K100163 | 2011-10-13 |
| K060944 | 2006-09-15 |
| K003311 | 2002-01-11 |
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.