BD Vacutainer® Trace Element K2 Edta (K2E) 10.8mg Blood Collection Tubes
The BD Vacutainer Trace Element K2EDTA tube collects venous whole blood for trace element testing. This configuration has a 6 mL draw volume in a 13 by 100 mm plastic tube. The evacuated…
The BD Vacutainer Trace Element K2EDTA tube collects venous whole blood for trace element testing. This configuration has a 6 mL draw volume in a 13 by 100 mm plastic tube.
The evacuated tube draws the sample into a closed container. Spray-dried EDTA on the inner wall acts as an anticoagulant. Its PET body is sealed by a Hemogard closure comprising a rubber stopper and protective plastic shield.
Listed Item
Tube Trce PLH 13X100 6.0 Uplbl R/BL Edta
Collection and Processing
The tube is supplied sterile for single use by trained healthcare professionals during blood collection, transport, and processing. Its royal blue closure identifies the trace element application, including tests for substances such as lead, copper, mercury, selenium, and zinc.
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) | K213953 |
| Record published | 2016-07-28 |
| Record revised | 2024-03-25 (version 6) |
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 |
| Packaging | Case of 10 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 368381 | 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 |
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.