What is FDA product code OEZ?

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.

Cardiovascular › DiagnosticCardiovascular Procedure Kit

Custom Healthcare Systems, Inc

Name: Custom Healthcare Systems, Inc
Brand: Custom Healthcare Systems, Inc

4 catalogue numbers from M100-19608, listed by Manus Medical, LLC, United States, under Cardiovascular Procedure Kit. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

4catalogue numbers in this listing

Who Else Makes It

Registered in Zhejiang.

Chinese manufacturers registered for FDA product code OEZ
Manufacturer	City	Province	Registered as	Device types
GRI Medical & Electronic Technology Co., Ltd.	Jiaxing	Zhejiang	Contract manufacturer	71

Record

Regulatory record for Custom Healthcare Systems, Inc
Listed by	Manus Medical, LLC, United States
FDA product code	OEZ
Device type	Cardiovascular Procedure Kit
Device class	Class 2
Regulation	21 CFR 870.1200
Establishment	Contract manufacturer, Contract steriliser, Repacker / relabeller, Manufacturer
Premarket notification	Exempt
Record published	2019-11-19
Record revised	2025-11-20 (version 6)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Ethylene Oxide
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Packaging	N/a of 5, n/a of 10, pack of 5, pack of 25

Catalogue Numbers

Catalogue numbers for Custom Healthcare Systems, Inc
Catalogue number	Size	Status
M100-19608		In distribution
UNC-17914		In distribution
M100		In distribution
CDWS-19145		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Cardinal Health	Cardinal Health 200, LLC	40,731
Medline Industries, Inc.	Medline Industries, Inc.	17,468
Avid TruCustom	Avid Medical, Inc.	2,785
Namic	Medline Industries, Inc.	2,718
Merit Medical®	Merit Medical Systems, Inc.	2,399
Halyard	Avid Medical, Inc.	2,108
ACS	American Contract Systems, Inc.	1,540
Medline	Medline Industries, Inc.	428
Stradis Healthcare	Stradis Healthcare	263
Regard™	ROi CPS LLC	192
Stradis	Stradis Healthcare	108
Regard™	Resource Optimization & Innovation, L.L.C.	72

Showing 12 of 52. All products under Cardiovascular Procedure Kit

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.