Fluid Systems Accessories
Air Eliminating 1.2 micrometer Solution Filter
1manufacturer
1catalogue number
4510(k) clearances naming this product code
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 | Baxter Healthcare Corporation, United States |
|---|---|
| FDA product code | FPB |
| Device type | Filter, Infusion Line |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5440 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2020-09-30 |
| Record revised | 2026-01-05 (version 4) |
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, manufacturing date |
| Storage | Special storage condition: Store at Room Temperature, Keep dry, Keep away from sunlight (or heat) |
| Packaging | Case of 50 |
| Sizes | Pressure 29 psi; total volume 0.8 ml; pore size 1.2e-06 m |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2N3368 | Pressure 29 psi | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medex | ICU Medical, Inc | 44 |
| Vygon | Vygon Corp. | 22 |
| 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 |
Showing 12 of 21. All products under Filter, Infusion Line
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K113227 | 2011-12-08 |
| K933869 | 1994-04-26 |
| K932301 | 1993-11-10 |
| K931441 | 1993-09-21 |
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.