Vygon
14" STANDARDBORE EXTENSION SET WITH 0.2 MICRON FILTER AND Y-SITE (APPROX. PRIMING VOLUME 4.9 mL)
1manufacturer
22catalogue numbers in this listing
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 7 |
Record
| Listed by | Vygon Corp., United States |
|---|---|
| FDA product code | FPB |
| Device type | Filter, Infusion Line |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5440 |
| 510(k) | K894954 |
| Record published | 2017-07-28 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 50, pack of 1000 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VYG-423-1 | In distribution | |
| AMS-427 | In distribution | |
| AMS-426-1 | In distribution | |
| AMS-423-1 | In distribution | |
| AMS-427 | In distribution | |
| AMS-582 | In distribution | |
| AMS-949 | In distribution | |
| AMS-423-1 | In distribution | |
| SS-426 | In distribution | |
| AMS-572 | In distribution | |
| AMS-426-1 | In distribution | |
| AMS-949 | In distribution | |
| AMS-426-1 | In distribution | |
| AMS-423-1 | In distribution | |
| AMS-948 | In distribution | |
| AMS-373 | In distribution | |
| VYG-423-1 | In distribution | |
| AMS-582 | In distribution | |
| AMS-427-NS | In distribution | |
| SS-426 | In distribution | |
| AMS-427 | In distribution | |
| AMS-948 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medex | ICU Medical, Inc | 44 |
| Pall Posidyne® ELD Filter | Global Life Sciences Solutions USA LLC | 5 |
| GRI-BAG | Laboratorios Grifols SA | 3 |
| Hemo-Nate | Utah Medical Products, Inc. | 3 |
| Filter, Infusion Line | Baxter Healthcare Corporation | 3 |
| Interlink | Baxter Healthcare Corporation | 3 |
| Pall Posidyne® NEO Filter | Global Life Sciences Solutions USA LLC | 2 |
| Hemo-TAP | Utah Medical Products, Inc. | 2 |
| Pall Supor® AEF Filter | Pall International Sàrl | 2 |
| Spectrum, Inc. | Spectrum Medical Ltd | 2 |
| WalkMed® | WalkMed Technologies, LLC | 2 |
| Medline Industries, Inc. | Medline Industries, Inc. | 2 |
Showing 12 of 21. All products under Filter, Infusion Line
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.