AMSure® Add-A-Foley Catheter Tray

FDA UDI

Class II (US FDA UDI)

by Amsino International, Inc.

Identity

Trade Name: AMSure® Add-A-Foley Catheter Tray FDA UDI
Generic Name: Intermittent urethral catheterization kit FDA UDI
Device Name: AMSure® Add-A-Foley Catheter Tray CONTENTS; 1 2000mL Drainage bag, 1 Wrap, 1 Drape, 2 Nitrile Gloves, 1 Fenestrate Drape, 1 Pkg. Povidone-Iodine Solution, 5 Rayon Balls, 1 Catheter Lubricating Jelly Sachet, 1 Plastic Forceps, 1 Specimen Container and Label, 1 10mL Syringe with Pre-filled Sterile Water FDA UDI
Model / Reference: 1 FDA UDI
Description: AMSure® Add-A-Foley Catheter Tray CONTENTS; 1 2000mL Drainage bag, 1 Wrap, 1 Drape, 2 Nitrile Gloves, 1 Fenestrate Drape, 1 Pkg. Povidone-Iodine Solution, 5 Rayon Balls, 1 Catheter Lubricating Jelly Sachet, 1 Plastic Forceps, 1 Specimen Container and Label, 1 10mL Syringe with Pre-filled Sterile Water FDA UDI

Identifiers

Catalog Number: AS89300 FDA UDI
Primary DI / UDI-DI: 10704411005292 FDA UDI
FDA Product Code: FCM 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

Yes

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

AMSure® Add-A-Foley Catheter Tray by Amsino International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Intermittent urethral catheterization kit.

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GLOBAL HEALTHCARE — GHC HEALTHCARE, INC. · Class II
MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
TruCath — H R Pharmaceuticals, Inc. · Class II
O'Neil Intermittent Urinary Catheter — GO MEDICAL INDUSTRIES PTY. LTD. · Class II
TruCath — H R Pharmaceuticals, 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

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Manufacturer

Manufacturer: Amsino International, Inc.

Sources (1)

FDA UDI 083d28f1-9ca1-4164-8d37-c0cb59eb95f8 34 fields · synced May 30, 2026