Filter NRFit
The Pajunk NRFit filter is an anesthesia conduction filter used during injection of local anesthetic to reduce particulate contamination of the injected fluid. It is intended for patients…
The Pajunk NRFit filter is an anesthesia conduction filter used during injection of local anesthetic to reduce particulate contamination of the injected fluid. It is intended for patients weighing at least 10 kg and connects within the compatible administration pathway.
A hydrophilic polyethersulfone membrane with 0.2 micrometer pores sits in a modified acrylic housing. The device has male and female connections with a rotating locking hub. This version uses the NRFit connector geometry.
Supply
The finished filter is supplied sterile for disposable use, with ethylene oxide sterilization. Its five-year shelf life applies to the validated sterile packaging. The NRFit connection must be matched to compatible neuraxial administration components.
Who Else Makes It
Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Runqiang Medical Instruments Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 9 |
Record
| Listed by | Pajunk Gmbh Medizintechnologie, Germany |
|---|---|
| FDA product code | BSN |
| Device type | Filter, Conduction, Anesthetic |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5130 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer |
| 510(k) | K190663 |
| Record published | 2020-07-22 |
| Record revised | 2026-01-12 (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 |
| Distribution end date | 2025-03-15 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 001163-39F | 10 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dash 6 | Gbuk Group Limited | 8 |
| Portex | ICU Medical, Inc | 6 |
| Millex-HV | Merck Millipore Ltd. | 3 |
| Filter | Pajunk Gmbh Medizintechnologie | 3 |
| Millex-OR | Merck Millipore Ltd. | 2 |
| Millex-HA | Merck Millipore Ltd. | 2 |
| Millex-GV | Merck Millipore Ltd. | 2 |
| Millex-FG | Merck Millipore Ltd. | 2 |
| Millex-MP | Merck Millipore Ltd. | 2 |
| Millex-GS | Merck Millipore Ltd. | 2 |
| Millex-HP | Merck Millipore Ltd. | 1 |
| Vented Millex-AA | Merck Millipore Ltd. | 1 |
Showing 12 of 22. All products under Filter, Conduction, Anesthetic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K190663 | 2019-06-17 |
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.