What is FDA product code OGV?

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

Medical Equipment Affiliates · Tracheostomy Cleaning Tray → Anesthesiology

Name: Medical Equipment Affiliates
Brand: Medical Equipment Affiliates

3manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Hubei (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 OGV
Manufacturer	City	Province	Registered as	Device types
Allmed Medical Products Co., Ltd.	Zhijiang	Hubei	Contract manufacturer	43
Amsino Medical (Shanghai) Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	22
Allmed Industrial Limited	Shenzhen	Guangdong	Manufacturer	42

Record

Regulatory record for Medical Equipment Affiliates
Listed by	Medline Industries, Inc., United States
FDA product code	OGV
Device type	Tracheostomy Cleaning Tray
Device class	Class 2
Regulation	21 CFR 868.5800
Premarket notification	Exempt
Record published	2021-04-02

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Over the counter	Yes
Supplied as a kit	Yes
Latex	Labelled latex-free
Label carries	lot or batch number
Packaging	Pack of 20
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Medical Equipment Affiliates
Catalogue number	Size	Status
DYK1101835T		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Medline	Medline Industries, Inc.	25
AirLife	Carefusion	6
Cardinal Health	Cardinal Health 200, LLC	6
Tracoe care	Tracoe Medical Gmbh	2
Professional Medical Surgical Supply, Inc. d / b / a International Direct	Professional Medical-Surgical Supply, Incorporated	2

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.

Medical Equipment Affiliates

Who Else Makes It

Record

Specifications

Catalogue Numbers

Same Product Code

Where China Actually Supplies