Portex
6 catalogue numbers from 24-1000-64, listed by ICU Medical, Inc, United States, under Filter, Conduction, Anesthetic. 1 manufacturer in China is registered for this product code.
1manufacturer
6catalogue numbers in this listing
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 | ICU Medical, Inc, United States |
|---|---|
| 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, Complaint-file establishment, Manufacturer |
| 510(k) | K172410 |
| Record published | 2020-03-09 |
| 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, manufacturing date |
| Packaging | Case of 10, pallet of 7, bag of 10, carton of 70, case of 50 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 24-1000-64 | In distribution | |
| 24-1356-64 | In distribution | |
| 100/386/010 | In distribution | |
| 24-1018-64 | In distribution | |
| 24-1024-64 | In distribution | |
| 100/386/010CZ | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dash 6 | Gbuk Group Limited | 8 |
| 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 |
| 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
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Smiths Medical Asd, Inc. | 510(k) number | 2020-12-08 | Class II | Error in labeling | The labeling was missing information on sterilization and prohibition of reuse. | 3420 devices | 2023-08-04 |
| Smiths Medical Asd, Inc. | 510(k) number | 2020-02-28 | Class II | Labeling mix-ups | Cases of Portex Lumbar Puncture Tray Child, SKU #4826PL-20 had been mislabeled with invalid information. The product was correct, but the inner trays were labeled as 4824PL-20 instead of 4826PL-20. | 100 units. | 2021-09-01 |
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.