What is FDA product code OJJ?

This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

General & Plastic Surgery › SurgicalBurn Kit Without Drug

Regard™

Name: Regard™
Brand: Regard™

3 catalogue numbers from GS0244, listed by Resource Optimization & Innovation, L.L.C., under Burn Kit Without Drug. 3 manufacturers in China are registered for this product code.

Registry build 21.09.26

3manufacturers in China registered for this device type

3catalogue numbers in this listing

Who Else Makes It

Concentrated in Shandong (1), Guangdong (1), Shanghai (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code OJJ
Manufacturer	City	Province	Registered as	Device types
Guangzhou Nuoning Medical Supplies Co., Ltd.	Guangzhou	Guangdong	Contract manufacturer	62
Shanghai Care Us Medical Product Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	30
Hynaut Health Technology Co., Ltd.	Qingdao	Shandong	Contract manufacturer	68

Record

Regulatory record for Regard™
Listed by	Resource Optimization & Innovation, L.L.C.
FDA product code	OJJ
Device type	Burn Kit Without Drug
Device class	Class 1
Regulation	21 CFR 878.4022
Premarket notification	Exempt
Record published	2019-01-01
Record revised	2020-08-27 (version 3)

Specifications

Specifications
MRI safety	MR Safe
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Packaging	Pack of 2
Distribution end date	2020-08-26

Catalogue Numbers

Catalogue numbers for Regard™
Catalogue number	Size	Status
GS0244		Withdrawn
GS0082		Withdrawn
GS0294		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Cardinal Health	Cardinal Health 200, LLC	517
Medline Industries, Inc.	Medline Industries, Inc.	142
ACS	American Contract Systems, Inc.	26
Regard™	ROi CPS LLC	10
DeRoyal	Deroyal Industries, Inc.	7
Medical Action Industries	Medical Action Industries, Inc.	4
Burnshield	Burnshield Usa, LLC	2
Centurion Medical Products Corp	Medline Industries, Inc.	2
First Responder Industrial Welding Burn Kit 5/Case	Safeguard US Operating, LLC	2
Burn Dressing Large – Red Velcro Bag	Certified Safety Manufacturing, Inc.	1
CVS Health	Woonsocket Prescription Center, Incorporated	1
BurnFree Burn Kit 10/Case	Safeguard US Operating, LLC	1

Showing 12 of 18. All products under Burn Kit Without Drug

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.