3m™ Kerralite Cool™

3M™ Kerralite Cool™ Border Moisture-Balancing Hydrogel Adhesive Dressing, CWL1007, 3 in x 3 in, 5/ct, 104ct/Cs

Registry build 21.09.26
118manufacturers in China registered for this device type
7catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (33), Jiangsu (23), Guangdong (17). 16 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code NAE
Manufacturer City Province Registered as Device types
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Hubei V-Medical Products Co., Ltd. Xiantao Hubei Contract manufacturer 46
Allmed Medical Products Co., Ltd. Zhijiang Hubei Contract manufacturer 43
Shanghai Care Us Medical Product Co., Ltd. Shanghai Shanghai Contract manufacturer 30
Henso Medical (Hangzhou) Co., Ltd. Hangzhou Zhejiang Contract manufacturer 19
Huizhou Foryou Medical Devices Co., Ltd. Huizhou Guangdong Contract manufacturer 18
Wuhan Huawei Technology Co., Ltd. Wuhan Hubei Contract manufacturer 16
Zhejiang Aoki Medical Dressing Co., Ltd. Wenzhou Zhejiang Contract manufacturer 16
Hanghai Medical Products Co Ltd Jinhua Zhejiang Contract manufacturer 10
Jiangsu Yizheng Carepro Medical Instruments Co., Ltd. Yizheng Jiangsu Contract manufacturer 8
Winner Medical (Jiayu) Co., Ltd. Jiayu Hubei Contract manufacturer 7
Smith & Nephew (Suzhou) Limited Suzhou Jiangsu Contract manufacturer 6

Showing 12 of 118. All 118 manufacturers in China registered for Dressing, Wound, Hydrogel Without Drug And/Or Biologic

Record

Regulatory record for 3M™ Kerralite Cool™
Listed by 3M Deutschland GmbH, Germany
FDA product code NAE
Device type Dressing, Wound, Hydrogel Without Drug And/Or Biologic
Device class Class 1
Regulation 21 CFR 878.4022
Establishment Specification developer, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2023-12-21

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, manufacturing date
Packaging Box of 52, box of 104, box of 32, box of 62, box of 114, box of 40

Catalogue Numbers

Catalogue numbers for 3M™ Kerralite Cool™
Catalogue number Size Per pack Status
CWL1008 5 In distribution
CWL1008-B550 550 In distribution
CWL1007 5 In distribution
CWL1009 5 In distribution
CWL1005 5 In distribution
CWL1004 5 In distribution
CWL1006 5 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Spand-Gel Medi-Tech, Inc. 16
BurnFree Water-JEL Technologies, L.L.C. 16
Simpurity Safe N Simple LLC 15
Lavior Lavior Pharma Inc. 9
McKesson Mckesson Medical-Surgical Inc. 8
Cutimed® BSN Medical, Inc. 8
H&H Tronjen Medical Technology Inc 7
First Responder Water-JEL Technologies, L.L.C. 6
Aquasite® Derma Sciences Canada, Inc. 5
DermaSyn Sion Brands LLC 5
Medline Medline Industries, Inc. 5
Leukomed® BSN Medical, Inc. 5

Showing 12 of 127. All products under Dressing, Wound, Hydrogel Without Drug And/Or Biologic

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