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

Opt-Shield

Name: Opt-Shield
Brand: Opt-Shield

Non sterile single use OR table drape with warm air circulating and safe patient positioning capabilities.

Registry build 21.09.26

8manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

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 Opt-Shield
Listed by	BCG Medical, LLC, United States
FDA product code	DWJ
Device type	System, Thermal Regulating
Device class	Class 2
Regulation	21 CFR 870.5900
Establishment	Specification developer, Manufacturer
Record published	2017-08-11
Record revised	2023-12-18 (version 7)

Specifications

Specifications
MRI safety	MR Safe
Single use	Yes
Prescription	Prescription only
Latex	Contains natural rubber latex
Label carries	lot or batch number, expiry date, manufacturing date, serial number
Storage	Storage environment temperature 40 to 90 °F
Packaging	Carton, carton of 5

Catalogue Numbers

Catalogue numbers for Opt-Shield
Catalogue number	Size	Status
OSA96X39LIT		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
K162562	2017-03-17

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.