BD Vacutainer® PST™ Gel and Lithium HeparinN 56 Units
BD Vacutainer® PST™ Gel and Lithium Heparin (N) 56 Units
23manufacturers in China registered for this device type
1catalogue number
18510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (7), Zhejiang (6), Shanghai (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Promisemed Hangzhou Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 21 |
| Beilun Plastech Inc | Ningbo | Zhejiang | Contract manufacturer | 13 |
| Weihai Jierui Medical Products Co., Ltd. | Weihai | Shandong | Contract manufacturer | 3 |
| Tianjin Hanaco Medical Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 3 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Zhejiang Medicines & Health Products I/ E Co., Ltd. | Hangzhou | Zhejiang | Exporter | 41 |
| Jiangsu Caina Medical Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 20 |
| Hangzhou Best Valley Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Exporter | 20 |
| Zhejiang Kindly Medical Devices Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 16 |
| Jiangsu Rongye Technology Co., Ltd. | Yangzhou | Jiangsu | Manufacturer | 16 |
| Yangzhou Medline Industry Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 11 |
| Shanghai Mekon Medical Devices Co., Ltd. | Shanghai | Shanghai | Exporter | 11 |
Showing 12 of 23. All 23 manufacturers in China registered for Tubes, Vials, Systems, Serum Separators, Blood Collection
Record
| Listed by | Becton, Dickinson AND Company, United States |
|---|---|
| FDA product code | JKA |
| Device type | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1675 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2016-07-28 |
| Record revised | 2026-05-21 (version 7) |
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 |
| Storage | Storage environment temperature 4 to 25 °C; Special storage condition: Keep away from sunlight |
| Packaging | Case of 10 |
| Sizes | Length 75 mm; total volume 3 ml |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 367960 | Diameter = 13 millimetre (mm) | 100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Portex | ICU Medical, Inc | 182 |
| S-Monovette® | Sarstedt Aktiengesellschaft & Co.KG | 108 |
| Vacuette | Greiner BIO-ONE Gmbh | 106 |
| Jelco | ICU Medical, Inc | 35 |
| Kbmed | KB Medical (Group) Inc. | 33 |
| Marketlab Inc | Marketlab Incorporated | 30 |
| Maveric Medical | Maveric Medical LLC | 27 |
| Safe-T-Fill® | Ram Scientific | 23 |
| Improvacuter® Gel & Clot Activator Tube | Guangzhou Improve Medical Instruments Co., Ltd. | 21 |
| Medline | Medline Industries, Inc. | 20 |
| Kurin Blood Culture Collection Set | Kurin, Inc. | 20 |
| Reli | Myco Medical Supplies, Inc. | 18 |
Showing 12 of 303. All products under Tubes, Vials, Systems, Serum Separators, Blood Collection
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260128 | 2026-04-15 |
| K252378 | 2026-04-10 |
| K252506 | 2026-04-10 |
| K252040 | 2026-03-13 |
| K243207 | 2025-07-03 |
| K243649 | 2025-03-21 |
| K242320 | 2024-11-01 |
| K231373 | 2024-02-02 |
| K231237 | 2024-01-19 |
| K230855 | 2023-12-20 |
| K230391 | 2023-12-01 |
| K213953 | 2023-07-17 |
| K220212 | 2023-03-24 |
| K222478 | 2023-03-10 |
| K212724 | 2022-02-04 |
| K202446 | 2020-09-25 |
| K160657 | 2016-09-23 |
| K153309 | 2016-02-12 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Becton, Dickinson & Co. | UDI-DI | 2019-06-12 | Class II | Device Design | False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument. | 1,436,228,004 total | 2020-06-29 |
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.