Portex
17 catalogue numbers from 24-1355-64, listed by ICU Medical, Inc, United States, under Needle, Conduction, Anesthetic (W/Wo Introducer). 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
17catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (5), Shanghai (2), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Runqiang Medical Instruments Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 9 |
| Ningbo Linstant Polymer Materials Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 1 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Zhejiang Medicines & Health Products I/ E Co., Ltd. | Hangzhou | Zhejiang | Exporter | 41 |
| Zhejiang Kindly Medical Devices Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 16 |
| Shanghai Mekon Medical Devices Co., Ltd. | Shanghai | Shanghai | Exporter | 11 |
| Tianjin Hanaco Medical Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 3 |
| Shanghai SA Medical & Plastic Instruments Co., Ltd. | Shanghai | Shanghai | Manufacturer | 1 |
Record
| Listed by | ICU Medical, Inc, United States |
|---|---|
| FDA product code | BSP |
| Device type | Needle, Conduction, Anesthetic (W/Wo Introducer) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5150 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K172823 |
| Record published | 2020-03-09 |
| Record revised | 2025-04-17 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Case of 10, case of 20, pallet of 10, box of 10 |
| Distribution end date | 2019-08-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 24-1355-64 | In distribution | |
| 24-1016-64 | In distribution | |
| 24-1014-64 | In distribution | |
| 24-1010-64 | In distribution | |
| 24-1011-64 | In distribution | |
| 4989-18/27 | In distribution | |
| 4911-20 | In distribution | |
| 24-1013-64 | In distribution | |
| 24-1023-64 | In distribution | |
| 24-1017-64 | In distribution | |
| 4990-20/24 | In distribution | |
| 24-1012-64 | In distribution | |
| 24-1015-64 | In distribution | |
| 4911-18 | In distribution | |
| 24-1354-64 | In distribution | |
| 4988-17/27 | In distribution | |
| PDX3143 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Halyard | Avanos Medical, Inc. | 386 |
| Sprotte® | Pajunk Gmbh Medizintechnologie | 273 |
| Avanos | Avanos Medical, Inc. | 264 |
| Epimed | Epimed International, Inc. | 131 |
| Phoenix | DR. Japan Co., Ltd. | 128 |
| Tuohy | Pajunk Gmbh Medizintechnologie | 128 |
| Lccs | Lccs Products Limited | 121 |
| Arrow | Teleflex Medical LLC | 104 |
| Reli | Myco Medical Supplies, Inc. | 86 |
| Sonoblock | Pajunk Gmbh Medizintechnologie | 70 |
| Temena | Temena GmbH | 67 |
| Sprotte® NRFit | Pajunk Gmbh Medizintechnologie | 63 |
Showing 12 of 149. All products under Needle, Conduction, Anesthetic (W/Wo Introducer)
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.