BD Vacutainer® Blood Alcohol Determinations Tube
Tube BAC GC 16X100 10.0 Plbl GR NAF/KOX
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 |
| Premarket notification | Exempt |
| Record published | 2016-08-22 |
| Record revised | 2024-03-25 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 4 to 25 °C |
| Packaging | Case of 10 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 367001 | 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
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Becton, Dickinson & Co. | UDI-DI | 2022-09-15 | Class II | Component design/selection | The affected product contains isobutylene which has recently demonstrated potential interference in determination of methanol by gas chromatography methods. The interference may lead to false positive results in methanol testing. | 2,196,000 | |
| Becton, Dickinson & Co. | UDI-DI | 2019-05-30 | Class II | Process control | Lot has been confirmed to have no additive within the tube. Sample processed without the preservative (additive) in the tube, testing has yielded reliable results if the samples were stored at room temperature for no longer than two days. | 247,000 tubes | 2020-05-05 |
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.