What is FDA product code OES?

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 › DiagnosticCardiac Catheterization Kit

Custom Healthcare Systems Inc.

Name: Custom Healthcare Systems Inc.
Brand: Custom Healthcare Systems Inc.

6 catalogue numbers from B9-18944, listed by Manus Medical, LLC, United States, under Cardiac Catheterization Kit. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

6catalogue numbers in this listing

Who Else Makes It

Registered in Zhejiang.

Chinese manufacturers registered for FDA product code OES
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	OES
Device type	Cardiac Catheterization Kit
Device class	Class 2
Regulation	21 CFR 870.1200
Establishment	Contract manufacturer, Contract steriliser, Repacker / relabeller, Manufacturer
Premarket notification	Exempt
Record published	2018-10-03
Record revised	2023-11-20 (version 5)

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, pack of 12, n/a of 10, n/a of 3
Distribution end date	2023-11-17

Catalogue Numbers

Catalogue numbers for Custom Healthcare Systems Inc.
Catalogue number	Size	Status
B9-18944		In distribution
CDWS-18374B		In distribution
B9-10335		In distribution
B9-17197		In distribution
CDWS-18821		In distribution
YMUVC-200		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Medline Industries, Inc.	Medline Industries, Inc.	7,486
Cardinal Health	Cardinal Health 200, LLC	2,706
Avid TruCustom	Avid Medical, Inc.	1,173
Centurion	Centurion Medical Products Corporation	1,077
Halyard	Avid Medical, Inc.	1,032
Medline Industries, Inc.	Centurion Medical Products Corporation	775
Medline	Medline Industries, Inc.	465
ACS	American Contract Systems, Inc.	344
Regard™	ROi CPS LLC	138
Regard™	Resource Optimization & Innovation, L.L.C.	79
Aligned Medical Solutions	Aligned Medical Solutions	72
Centurion Medical Products Corp	Medline Industries, Inc.	24

Showing 12 of 18. All products under Cardiac Catheterization 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.