Interlink
Y-Type Blood/Solution Set with 40 and 150 Micron Dual Screen Filter and Pressure Pump, Injection Site, Male Luer Lock Adapter with Retractable Collar
1manufacturer
3catalogue numbers in this listing
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 |
| 510(k) | K113227 |
| Record published | 2016-09-24 |
| Record revised | 2023-07-20 (version 7) |
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 |
| Packaging | Case of 48, case of 4, pack of 50 |
| Distribution end date | 2020-06-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2N3333 | In distribution | |
| 1C8740 | In distribution | |
| 4C6839 | Withdrawn |
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 |
| 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
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.