BD Microtainer® SST™ – Amber
Tube Micro W/Microgard SST GLD/AMB
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 |
| 510(k) | K991702 |
| Record published | 2016-07-28 |
| Record revised | 2024-02-26 (version 5) |
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 up to 25 °C |
| Packaging | Case of 4 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 365978 | 50 | 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
9 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 |
|---|---|---|---|---|---|---|---|
| Becton, Dickinson & Co. | 510(k) number | 2019-05-13 | Class II | Process control | Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results. | 2020-08-06 | |
| Becton, Dickinson & Co. | 510(k) number | 2019-05-13 | Class II | Process control | Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results. | 2020-08-06 | |
| Becton, Dickinson & Co. | 510(k) number | 2019-05-13 | Class II | Process control | Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results. | 2020-08-06 | |
| Becton, Dickinson & Co. | 510(k) number | 2019-05-13 | Class II | Process control | Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results. | 2020-08-06 | |
| Becton, Dickinson & Co. | 510(k) number | 2019-05-13 | Class II | Process control | Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results. | 2020-08-06 | |
| Becton, Dickinson & Co. | 510(k) number | 2019-05-13 | Class II | Process control | Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results. | 2020-08-06 | |
| Becton, Dickinson & Co. | 510(k) number | 2019-05-13 | Class II | Process control | Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results. | 2020-08-06 | |
| Becton, Dickinson & Co. | 510(k) number | 2019-05-13 | Class II | Process control | Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results. | 2020-08-06 | |
| Becton, Dickinson & Co. | 510(k) number | 2004-08-20 | Not classified | Other | “Please be aware that this is not a new recall. This recall was initially classified in 2005 (Z-0052-05). The firm has taken action; but, due to administrative issues additional products are now being classified by the agency”. There is an | There is no linkage to any particular lot of BD product |
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.