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.

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

Name: Curaplex
Brand: Curaplex

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 Curaplex
Listed by	Bound Tree Medical, LLC, United States
FDA product code	OJR
Device type	Vacuum Powered Body Fluid Collection Kit
Device class	Class 2
Regulation	21 CFR 878.4780
Establishment	Manufacturer
Premarket notification	Exempt
Record published	2016-12-14
Record revised	2018-03-29 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Latex	Labelled latex-free
Label carries	lot or batch number

Catalogue Numbers

Catalogue numbers for Curaplex
Catalogue number	Size	Status
812-CHEST		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
ACS	American Contract Systems, Inc.	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.

Curaplex

Who Else Makes It

Record

Specifications

Catalogue Numbers

Same Product Code

Where China Actually Supplies