What is FDA product code OJW?

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 › SurgicalShave Prep Kit

Holter Prep Kit

Name: Holter Prep Kit
Brand: Holter Prep Kit

Holter prep kit Each prep kit contains: 1 razor 1 alcohol pad 1 AA battery 1 skin scrubby 1 page of 5 wet gel electrodes 1 patient diary

Registry build 21.09.26

1manufacturer

1catalogue number

Who Else Makes It

Registered in Guangdong.

Chinese manufacturers registered for FDA product code OJW
Manufacturer	City	Province	Registered as	Device types
Shenzhen Fox Hunting E-commerce Co., Ltd.	Shenzhen	Guangdong	Exporter	7

Record

Regulatory record for Holter Prep Kit
Listed by	VectraCor, Inc., United States
FDA product code	OJW
Device type	Shave Prep Kit
Device class	Class 2
Regulation	21 CFR 878.4370
Establishment	Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification	Exempt
Record published	2016-09-26
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
Label carries	expiry date

Catalogue Numbers

Catalogue numbers for Holter Prep Kit
Catalogue number	Size	Per pack	Status
701900-00		25	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Cardinal Health	Cardinal Health 200, LLC	50

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.