What is FDA product code OHM?

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.

Centurion Medical Products Corp · Cesarean Section Tray → Obstetrics & Gynecology

Name: Centurion Medical Products Corp
Brand: Centurion Medical Products Corp

3manufacturers in China registered for this device type

6catalogue numbers in this listing

Who Else Makes It

Concentrated in Anhui (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code OHM
Manufacturer	City	Province	Registered as	Device types
Sino Protection (Hefei) Medical Products Co., Ltd.	Hefei	Anhui	Contract manufacturer	18
GRI Medical & Electronic Technology Co., Ltd.	Jiaxing	Zhejiang	Contract manufacturer	71
Anhui Medical Sterilizing Co., Ltd.	Hefei	Anhui	Contract manufacturer	8

Record

Regulatory record for Centurion Medical Products Corp
Listed by	Medline Industries, Inc., United States
FDA product code	OHM
Device type	Cesarean Section Tray
Device class	Class 2
Regulation	21 CFR 884.1720
Premarket notification	Exempt
Record published	2022-03-27
Record revised	2022-06-17 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date
Packaging	Case of 5, case of 10, case of 3

Catalogue Numbers

Catalogue numbers for Centurion Medical Products Corp
Catalogue number	Size	Status
MNS13635		In distribution
MNS15550A		In distribution
MNS15550		In distribution
OR1626A		In distribution
MNS13635A		In distribution
MNS13820		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Cardinal Health	Cardinal Health 200, LLC	7,091
Medline Industries, Inc.	Medline Industries, Inc.	5,487
ACS	American Contract Systems, Inc.	533
Regard™	ROi CPS LLC	78
DeRoyal	Deroyal Industries, Inc.	32
Regard™	Resource Optimization & Innovation, L.L.C.	32
Medline	Medline Industries, Inc.	7
Invenio	GRI Medical & Electronic Technology Co., Ltd.	6
Aligned Medical Solutions	Aligned Medical Solutions	3
Henry Schein	Henry Schein, Inc.	2
Halyard	Avid Medical, Inc.	2
Invenio	GRI-Alleset, Inc.	1

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of Centurion Medical Products Corp
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Medline Industries, LP – Northfield	UDI-DI	2025-03-03	Class II	Under Investigation by firm	There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.	1098 units

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.

Centurion Medical Products Corp