Multi-Sample Blood Collection Set

A sharp bevel-edged, hollow tubular metal instrument intended to be used as part of a blood collection set for drawing blood from a patient. It is intended to be connected to blood…

Registry build 21.09.26

A sharp bevel-edged, hollow tubular metal instrument intended to be used as part of a blood collection set for drawing blood from a patient. It is intended to be connected to blood collection tubing and/or a blood collection Luer connector for transfer into a blood specimen receptacle. It may include a pre-attached blood collection tube spike however it does not include a blood collection tube holder. This is a single-use device.

23manufacturers in China registered for this device type
3catalogue numbers in this listing
4510(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.

Chinese manufacturers registered for FDA product code JKA
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

Regulatory record for Multi-Sample Blood Collection Set
Listed by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd., China
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, Manufacturer, Exporter
510(k) K202188
Record published 2022-05-20

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Latex Contains natural rubber latex
Label carries lot or batch number, expiry date
Packaging Pack of 50, pack of 20

Catalogue Numbers

Catalogue numbers for Multi-Sample Blood Collection Set
Catalogue number Size Status
25G X 3/4″ In distribution
23G X 3/4″ In distribution
21G x 3/4″ In distribution

Same Product Code

Other products under the same FDA 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

FDA 510(k) clearances naming this product code
Clearance Decision date
K223323 2023-03-24
K222141 2022-10-21
K220900 2022-08-10
K202188 2021-02-19

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer