Epimed
Epidural Flat Filter
1manufacturer
1catalogue number
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 | Epimed International, Inc., 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, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2017-10-24 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Handling environment temperature 50 to 90 °F |
| Packaging | Case of 10 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1911-498 | 6.0″ | 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
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.