Improvacuter® Gel & Clot Activator Tube

This is the Conventional Closure Configurations of IMPROVACUTER® Gel &Clot Activator Tube with the components of Tube, Closure, Clot Activator as well as Serum separating Gel. And the…

Registry build 21.09.26

This is the Conventional Closure Configurations of IMPROVACUTER® Gel &Clot Activator Tube with the components of Tube, Closure, Clot Activator as well as Serum separating Gel. And the Closure is only made up of Rubber Stopper without Safety Cap. The material of Rubber Stopper is Halogenated butyl rubber.

23manufacturers in China registered for this device type
21catalogue numbers in this listing
1510(k) clearance

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 Improvacuter® Gel & Clot Activator Tube
Listed by Guangzhou Improve Medical Instruments 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, Specification developer, Manufacturer
510(k) K093910
Record published 2016-12-26
Record revised 2021-11-10 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Label carries lot or batch number, expiry date
Packaging Pack of 10, pack of 20

Catalogue Numbers

Catalogue numbers for Improvacuter® Gel & Clot Activator Tube
Catalogue number Size Per pack Status
16x100mm,7ml 50 In distribution
13x100mm,4ml 100 In distribution
16x100mm,7.5ml 50 In distribution
16×100mm,8.5ml 50 In distribution
13x75mm,3.5ml 100 In distribution
16x100mm,8ml 50 In distribution
13x100mm,5ml 100 In distribution
16×100mm,8ml 50 In distribution
13×75mm,3.5ml 100 In distribution
16x100mm,8.5ml 50 In distribution
13x100mm,3ml 100 In distribution
13x75mm,4ml 100 In distribution
16x100mm,6ml 50 In distribution
13×75mm,3ml 100 In distribution
16×100mm,6ml 50 In distribution
16×100mm,7ml 50 In distribution
13x100mm,6ml 100 In distribution
13×100mm,4ml 100 In distribution
16x100mm,8.5ml 50 In distribution
13x75mm,3ml 100 In distribution
13×100mm,5ml 100 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
Medline Medline Industries, Inc. 20
Kurin Blood Culture Collection Set Kurin, Inc. 20
Reli Myco Medical Supplies, Inc. 18
icu medical Jiangsu Caina Medical Co., Ltd. 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
K093910 2010-07-12

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.

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