What is FDA product code OJS?

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

General & Plastic Surgery › TherapeuticTourniquet Kit

Curaplex

Name: Curaplex
Brand: Curaplex

Curaplex IV Start Kit w/Curaplex IV Guard, 6 in Ext Set, 10ml Flush Syringe,Swab,Gauze,LF Tourniquet

Registry build 21.09.26

2manufacturers in China registered for this device type

8catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (1), elsewhere (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code OJS
Manufacturer	City	Province	Registered as	Device types
Hangzhou Rollmed Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	127
Caremax Co., Ltd.	Suzhou, Jiangsu Province		Contract manufacturer	17

Record

Regulatory record for Curaplex
Listed by	Bound Tree Medical, LLC, United States
FDA product code	OJS
Device type	Tourniquet Kit
Device class	Class 1
Regulation	21 CFR 878.5900
Establishment	Manufacturer
Premarket notification	Exempt
Record published	2016-12-14
Record revised	2022-08-16 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Latex	Contains natural rubber latex
Label carries	lot or batch number, expiry date
Packaging	Case of 15, case of 100, case of 50
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Curaplex
Catalogue number	Size	Status
1880-93102D		In distribution
660488		In distribution
8600-01392		In distribution
16714		In distribution
8600-01367		In distribution
1840-38001-A		In distribution
8600-01368		In distribution
1840-92306		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Cardinal Health	Cardinal Health 200, LLC	5
DeRoyal	Deroyal Industries, Inc.	4
Direct IV Solutions – IV Start Kit	Lynn Medical Instrument Co	4
Argyle	Cardinal Health	4
Ellman-Cot	Cynosure, LLC	3
SAM Bleeding Control Kit	SAM Medical Products	2
Argyle	Cardinal Health 200, LLC	1
Ellman Cots	Cynosure, LLC	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.