Filter
Filter 0,2µm, sterile
1manufacturer
3catalogue numbers in this listing
1510(k) clearance
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 | 2025-04-04 |
| Record revised | 2026-01-12 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 10 to 30 °C; Storage environment humidity 20 to 65 % RH |
| Packaging | Pack of 10 |
| Sizes | Pore size 0.2 µm |
| Distribution end date | 2024-12-28 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 001151-62 | Pore Size 0.2 µm | In distribution | |
| 001163-38K | 10 | Withdrawn | |
| 001163-39F | 10 | Withdrawn |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 |
| 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 |
| Filter NRFit | Pajunk Gmbh Medizintechnologie | 1 |
| 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.