Filter Needle for Single Use
The Filter Needle for Single Use is intended for drawing up, filtering and preparing medicinal fluid. It connects to compatible Luer-taper infusion equipment for manual fluid preparation…
The Filter Needle for Single Use is intended for drawing up, filtering and preparing medicinal fluid. It connects to compatible Luer-taper infusion equipment for manual fluid preparation and is not intended for injection. Model FN-B1838RW is an 18-gauge needle with a 38 mm length.
The assembly contains a cap, needle cannula, hub, sheath and filter. Its stainless-steel needle tube provides the fluid pathway, while a polyamide filter is incorporated into the device. The cap, hub and sheath are made from polycarbonate.
Listed Item
The Filter Needle for Single Use consists of cap, needle cannula,needle hub, sheath and filter. This product is intended for the aspiration, filtration and preparation of medical fluid, not including injection.
Connection and Supply
The hub uses a standard 6% tapered connector for equipment conforming to ISO 80369-7. The needle is supplied sterilized by irradiation and is intended for a single use under prescription.
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 | Hangzhou Qiantang Longyue Biotechnology Co., Ltd., China |
|---|---|
| FDA product code | FPB |
| Device type | Filter, Infusion Line |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5440 |
| Establishment | Manufacturer |
| 510(k) | K233277 |
| Record published | 2026-04-11 |
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 |
| Packaging | Secondary box of 200, carton of 8 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FN-B1838RW | 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 |
|---|---|
| K233277 | 2024-05-10 |
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.