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.

Obstetrics & Gynecology › DiagnosticCesarean Section Tray

Halyard

Name: Halyard
Brand: Halyard

2 catalogue numbers from GOCS34-01, listed by Avid Medical, Inc., United States, under Cesarean Section Tray. 3 manufacturers in China are registered for this product code.

Registry build 21.09.26

3manufacturers in China registered for this device type

2catalogue 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 Halyard
Listed by	Avid Medical, 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	2025-09-12

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
Storage	Special storage condition: STORE AT ROOM TEMPERATURE
Packaging	Pack of 3, pack of 4
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Halyard
Catalogue number	Size	Status
GOCS34-01		In distribution
ROCS82-01		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
Centurion Medical Products Corp	Medline Industries, Inc.	6
Aligned Medical Solutions	Aligned Medical Solutions	3
Henry Schein	Henry Schein, Inc.	2
Invenio	GRI-Alleset, 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.