TruCath

FDA UDI

Class II (US FDA UDI)

by H R Pharmaceuticals, Inc.

Identity

Trade Name: TruCath FDA UDI
Generic Name: Intermittent urethral catheterization kit FDA UDI
Device Name: TruCath Closed System Catheter Kit FDA UDI
Model / Reference: CK12 FDA UDI
Description: TruCath Closed System Catheter Kit FDA UDI

Identifiers

Catalog Number: CK12 FDA UDI
Primary DI / UDI-DI: 00851809002531 FDA UDI
FDA Product Code: FCM FDA UDI
KOD FDA UDI
GMDN Term: Intermittent urethral catheterization kit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5130 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Intermittent urethral catheterization kit

TruCath by H R Pharmaceuticals, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intermittent urethral catheterization kit.

O'Neil Intermittent Urinary Catheter — GO MEDICAL INDUSTRIES PTY. LTD. · Class II
MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
AMSure® Add-A-Foley Catheter Tray — AMSINO INTERNATIONAL, INC. · Class II
GLOBAL HEALTHCARE — GHC HEALTHCARE, INC. · Class II
MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
AMSure® Pre-Connected Urethral Tray — AMSINO INTERNATIONAL, INC. · Class II
O'Neil Intermittent Urinary Catheter — GO MEDICAL INDUSTRIES PTY. LTD. · Class II
AMSure® Urethral Self Catheterization Kit — AMSINO INTERNATIONAL, INC. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: H R Pharmaceuticals, Inc.

Sources (1)

FDA UDI 7d7a44ed-98d5-436c-8c58-f141ec60daae 35 fields · synced May 30, 2026