Kenaflexx

IV Administration SET, 84", 20 Drops/ML, Kentron Gravito Dial Flow Controller, 2 Ken_sef Split Septum Y Sites, Universal Spike, 15 Micron Filter, Back Check Valve, Ken_rol Male Rotating…

Registry build 21.09.26

IV Administration SET, 84″, 20 Drops/ML, Kentron Gravito Dial Flow Controller, 2 Ken_sef Split Septum Y Sites, Universal Spike, 15 Micron Filter, Back Check Valve, Ken_rol Male Rotating Luer Lock Connector, Flow Regulating Controller.

8manufacturers in China registered for this device type
49catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (3), Jiangsu (3), Hong Kong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LHI
Manufacturer City Province Registered as Device types
GRI Medical & Electronic Technology Co., Ltd. Jiaxing Zhejiang Contract manufacturer 71
Suzhou Jinsheng Plastic Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
Ming FAI Industrial (Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 17
Gcmedica Enterprise Ltd.(Wuxi) Wuxi Jiangsu Contract manufacturer 55
Steris Sterilization Technologies (Suzhou) Ltd Suzhou Jiangsu Contract manufacturer 44
Ming FAI Enterprise International Co., Ltd. Kowloon Hong Kong Exporter 18
Zhejiang Medtec Medical devices Co., Ltd. Hangzhou Zhejiang Manufacturer 10
Hangzhou Qiantang Longyue Biotechnology Co., Ltd. Hangzhou Zhejiang Manufacturer 7

Record

Regulatory record for Kenaflexx
Listed by Kentron Healthcare, Inc.
FDA product code LHI
Device type Set, I.V. Fluid Transfer
Device class Class 2
Regulation 21 CFR 880.5440
Record published 2018-11-18
Record revised 2021-04-07 (version 4)

Specifications

Specifications
MRI safety MR Safe
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date
Packaging Case of 50, case of 100
Sizes Length 5.7 to 110 in

Catalogue Numbers

Catalogue numbers for Kenaflexx
Catalogue number Size Status
937016 Length 85 in In distribution
936401 In distribution
937025 Length 92 in In distribution
439006 In distribution
439008 In distribution
940020 Length 20 in In distribution
937020 Length 100 in In distribution
940014 Length 12 in In distribution
940013 Length 12 in In distribution
948462 Length 84 in In distribution
943373 Length 6 in In distribution
429006 Length 6 in In distribution
936424 In distribution
4180102 In distribution
419010 In distribution
948402 Length 76 in In distribution
943378 In distribution
429018 Length 8 in In distribution
940035 Length 35 in In distribution
936425 In distribution
937062 Length 78 in In distribution
943371 Length 5.7 in In distribution
943375 Length 6.6 in In distribution
419015 In distribution
101006 In distribution
429016 In distribution
943384 Length 9 in In distribution
429000 In distribution
106006 In distribution
950020 Length 20 in In distribution
937063 Length 75 in In distribution
419060 In distribution
101506 In distribution
942379 Length 86 in In distribution
940012 Length 12 in In distribution
937015 Length 78 in In distribution
936402 In distribution
950006 Length 6 in In distribution
948420 In distribution
943374 Length 8 in In distribution
937029 Length 92 in In distribution
429010 Length 10 in In distribution
940006 Length 6 in In distribution
961150 Length 96 in In distribution
950035 In distribution
948460 Length 84 in In distribution
948519 In distribution
948421 Length 84 in In distribution
948537 Length 110 in In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Set, I.V. Fluid Transfer Mps Medical, Inc. 27
Vial Adaptor West Pharma. Services IL, Ltd. 26
Vial Adapter West Pharma. Services IL, Ltd. 22
Extension SET MPS Pharma & Medical, Inc. 19
Vial Adapter Medic’up Union Plastic 17
Exactamix Baxter Healthcare Corporation 16
Mix2Vial Transfer Device West Pharma. Services IL, Ltd. 15
Arisure Yukon Medical, LLC 13
ViaLok Yukon Medical, LLC 12
ICU Medical ICU Medical, Inc 12
Codan Codan US Corp. 10
SmartSite Yukon Medical, LLC 10

Showing 12 of 233. All products under Set, I.V. Fluid Transfer

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