What is FDA product code OHR?

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.

Gastroenterology & Urology › TherapeuticCatheter Care Tray

TMM-FC (Tactical Medical Module – Foley Catheter)

Catalogue number 5006, listed by Altitude Technologies Inc., under Catheter Care Tray. 12 manufacturers in China are registered for this product code.

Registry build 21.09.26

12manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Jiangsu (7), Zhejiang (4), Shanghai (1). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code OHR
Manufacturer	City	Province	Registered as	Device types
Amsino Medical (Kunshan) Co., Ltd.	Kunshan	Jiangsu	Contract manufacturer	53
Conod Medical Co., Limited	Changshu	Jiangsu	Contract manufacturer	48
Conod Medical Shuyang Co., Ltd.	Shuyang	Jiangsu	Contract manufacturer	22
Primecare Medical (Suzhou) Co., Ltd.	Changshu	Jiangsu	Contract manufacturer	20
Suzhou Jingle Polymer Medical Apparatus Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	19
Hangzhou Jimushi Meditech Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	6
Shaoxing Fuqing Health Products Co., Ltd.	Shaoxing	Zhejiang	Contract manufacturer	3
Jiangsu NEW Pentastar Medical Products Co., Ltd.	Changzhou	Jiangsu	Exporter	146
Sterigenics Shanghai ETO Ltd.	Shanghai	Shanghai	Contract manufacturer	65
Changshu Rozer Sterilization Technology Co., Ltd.	Changshu	Jiangsu	Contract manufacturer	43
Joykey Industrial (Pinghu) Limited	Pinghu	Zhejiang	Contract manufacturer	43
Hangzhou Primecare Medical Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	29

Record

Regulatory record for TMM-FC (Tactical Medical Module – Foley Catheter)
Listed by	Altitude Technologies Inc.
FDA product code	OHR
Device type	Catheter Care Tray
Device class	Class 2
Regulation	21 CFR 876.5130
Premarket notification	Exempt
Record published	2018-05-15
Record revised	2024-10-04 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Label carries	lot or batch number, expiry date
Distribution end date	2024-10-03

Catalogue Numbers

Catalogue numbers for TMM-FC (Tactical Medical Module – Foley Catheter)
Catalogue number	Size	Status
5006		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Medline	Medline Industries, Inc.	267
Medline Industries, Inc.	Medline Industries, Inc.	75
TruAdvance™	HR Pharmaceuticals Inc.	29
Cardinal Health	Cardinal Health 200, LLC	16
VaPro Plus Pocket Kit	Hollister Incorporated	10
LSL Healthcare	Lsl Industries, Inc.	8
Duette™	Poiesis Medical, LLC	8
Centurion Medical Products Corp	Medline Industries, Inc.	6
Medical Action Industries	Medical Action Industries, Inc.	5
TruCath	HR Pharmaceuticals Inc.	5
McKesson	Mckesson Medical-Surgical Inc.	5
Closed System Foley Catheter Tray, Pre-Connected Closed Circuit: 12 Fr	Dynarex Corp.	4

Showing 12 of 42. All products under Catheter Care Tray

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.