TruAdvance™

TruAdvance® 100% Silicone Dual-Balloon Foley Catheter Tray with Urine Meter

Registry build 21.09.26
12manufacturers in China registered for this device type
29catalogue 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 TruAdvance™
Listed by HR Pharmaceuticals Inc.
FDA product code OHR
Device type Catheter Care Tray
Device class Class 2
Regulation 21 CFR 876.5130
Premarket notification Exempt
Record published 2026-03-06

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Latex Contains natural rubber latex
Label carries lot or batch number, expiry date
Packaging Case of 10, case of 20, pack of 10

Catalogue Numbers

Catalogue numbers for TruAdvance™
Catalogue number Size Status
TAC14 In distribution
FTLS16UM In distribution
FTLS14DB In distribution
FTAC00DB In distribution
FTLS16DB In distribution
FTSS18DB In distribution
FIT10BZK In distribution
FTLS18DB In distribution
FTLC16DB In distribution
FIT30BZK In distribution
FTTS18UM In distribution
FIT30PVP In distribution
FTLS14UM In distribution
FTSS18UM In distribution
FTLS18UM In distribution
FTDS14UM In distribution
FTDS16UM In distribution
FIT10PVP In distribution
DIT10PVP In distribution
TAS14 In distribution
FTSS14UM In distribution
FTSS16DB In distribution
FTDS18UM In distribution
FTAC00UM In distribution
FTLC16UM In distribution
FTTS16UM In distribution
FTSS16UM In distribution
FTTS14UM In distribution
FTSS14DB 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
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
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