What is FDA product code DWJ?

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Cardiovascular › TherapeuticSystem, Thermal Regulating

Cocoon Convective Warming Machine, Model CWS7000

Name: Cocoon Convective Warming Machine, Model CWS7000
Brand: Cocoon Convective Warming Machine, Model CWS7000

Catalogue number CWS7000, listed by Care Essentials PTY Ltd, Australia, under System, Thermal Regulating. 8 manufacturers in China are registered for this product code.

Registry build 21.09.26

8manufacturers in China registered for this device type

1catalogue number

3510(k) clearances naming this product code

2recalls on this code

Who Else Makes It

Concentrated in Jiangsu (3), Shanghai (1), Anhui (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DWJ
Manufacturer	City	Province	Registered as	Device types
Sino Protection (Hefei) Medical Products Co., Ltd.	Hefei	Anhui	Contract manufacturer	18
Jiangyin Sinbon Electronics Co Ltd	Jiangyin	Jiangsu	Contract manufacturer	13
Copious Intl., Inc.	Heyuan, Guangdong Province		Contract manufacturer	11
Jiangyin Puremed	Jiangyin	Jiangsu	Contract manufacturer	7
Betacera Inc.	Suzhou	Jiangsu	Contract manufacturer	3
Shanghai Xodus Medical Company Limited	Shanghai	Shanghai	Specification developer	25
Hangzhou Tappa Medical Technology Co., Ltd.	Hangzhou	Zhejiang	Manufacturer	3
Jiangmen Dacheng Medical Equipment Co., Ltd.	Jiangmen	Guangdong	Contract manufacturer	1

Record

Regulatory record for Cocoon Convective Warming Machine, Model CWS7000
Listed by	Care Essentials PTY Ltd, Australia
FDA product code	DWJ
Device type	System, Thermal Regulating
Device class	Class 2
Regulation	21 CFR 870.5900
Establishment	Contract manufacturer, Manufacturer
Record published	2024-04-04
Record revised	2025-07-02 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Latex	Labelled latex-free
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Cocoon Convective Warming Machine, Model CWS7000
Catalogue number	Size	Status
CWS7000		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Mistral-Air	The Surgical Company International B.V.	114
Bair Hugger™	3M Company	99
IOB	Jiangmen Dacheng Medical Equipment Co., Ltd.	68
IOB	Iob Medical, Inc.	61
3M™ Bair Hugger™	3M Company	61
Cocoon	Care Essentials PTY Ltd	59
Soft Air	Adroit Medical Systems, Inc.	56
Level 1	ICU Medical, Inc	49
System, Thermal Regulating	Hangzhou Tappa Medical Technology Co., Ltd.	47
PremierPro	Prestige Ameritech	39
Bair Paws™	3M Company	30
SourceMark	Sourcemark, LLC.	25

Showing 12 of 166. All products under System, Thermal Regulating

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K232502	2024-02-21
K181671	2019-05-02
K140635	2014-07-25

Recalls

2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2020-01-07	Class II	Other	Potential for thermal damage near the power cord connector and Power Entry Module (PEM) due to improper connection of the power cord connector and PEM pins on the Cocoon Convective Warming System.	689	2023-03-22
2020-01-07	Class II	Other	Potential for thermal damage near the power cord connector and Power Entry Module (PEM) due to improper connection of the power cord connector and PEM pins on the Cocoon Convective Warming System.	251	2023-03-22

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.