Cardinal Health

Foley Insertion Tray w/Prefilled 10cc Syringe

Registry build 21.09.26
12manufacturers in China registered for this device type
16catalogue numbers in this listing

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 Cardinal Health
Listed by Cardinal Health 200, LLC, United States
FDA product code OHR
Device type Catheter Care Tray
Device class Class 2
Regulation 21 CFR 876.5130
Establishment Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2016-09-14
Record revised 2018-07-19 (version 3)

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, manufacturing date
Storage Storage environment temperature 15 to 30 °C
Packaging Case of 20, case of 4, case of 2

Catalogue Numbers

Catalogue numbers for Cardinal Health
Catalogue number Size Status
CIT10CC In distribution
CIT30CCBZN In distribution
SBA18CTAM6 In distribution
CIT30CC In distribution
CIT10CCBZK In distribution
SBA18CTAM5 In distribution
19-2511L In distribution
CIT10CCBZN In distribution
19-2511I In distribution
SBA18CTAM4 In distribution
SAN18CTAM1 In distribution
19-2511F In distribution
19-2511H In distribution
SBA18CTAM2 In distribution
CIT30CCBZK In distribution
SAN18CTAMA In distribution

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
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
Bardia® Foley Catheter Insertion Tray C.R. Bard, Inc. 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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer