What is FDA product code OJR?

This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. 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.

ACS · Vacuum Powered Body Fluid Collection Kit → General & Plastic Surgery

Name: ACS
Brand: ACS

1manufacturer

1catalogue number

Who Else Makes It

Registered in Guangdong.

Chinese manufacturers registered for FDA product code OJR
Manufacturer	City	Province	Registered as	Device types
Shenzhen BI-Rich Medical Devices Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	9

Record

Regulatory record for ACS
Listed by	American Contract Systems, Inc.
FDA product code	OJR
Device type	Vacuum Powered Body Fluid Collection Kit
Device class	Class 2
Regulation	21 CFR 878.4780
Premarket notification	Exempt
Record published	2019-09-16
Record revised	2022-06-17 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Ethylene Oxide
Supplied sterile	Yes
Single use	Yes
Supplied as a kit	Yes
Label carries	lot or batch number, serial number

Catalogue Numbers

Catalogue numbers for ACS
Catalogue number	Size	Status
SJBE44E		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Curaplex	Bound Tree Medical, LLC	1
Medline	Medline Industries, Inc.	1

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.

ACS

Who Else Makes It

Record

Specifications

Catalogue Numbers

Same Product Code

Where China Actually Supplies