AMSure® Foley Insertion Tray

FDA UDI

Class II (US FDA UDI)

by Amsino International, Inc.

Identity

Trade Name: AMSure® Foley Insertion Tray FDA UDI
Generic Name: Intermittent urethral catheterization kit FDA UDI
Device Name: AMSure® Foley Insertion Tray CONTENTS: 1 each 1000mL Outer Basin Tray 1 each Prefilled 30cc Syringe of Sterile Water 1 pair Vinyl Gloves 1 each Waterproof Drape 1 each Fenestrated Drape 1 pack Lubricating Jelly 1 pack PVP Swabsticks (3) FDA UDI
Model / Reference: 1 FDA UDI
Description: AMSure® Foley Insertion Tray CONTENTS: 1 each 1000mL Outer Basin Tray 1 each Prefilled 30cc Syringe of Sterile Water 1 pair Vinyl Gloves 1 each Waterproof Drape 1 each Fenestrated Drape 1 pack Lubricating Jelly 1 pack PVP Swabsticks (3) FDA UDI

Identifiers

Catalog Number: AS890-02 FDA UDI
Primary DI / UDI-DI: 10704411008033 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

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

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

Similar devices

Also classified as Intermittent urethral catheterization kit.

TruCath — H R Pharmaceuticals, Inc. · Class II
O'Neil Intermittent Urinary Catheter — GO MEDICAL INDUSTRIES PTY. LTD. · Class II
MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
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 1a5e24a7-c1e7-437c-8cf6-2e86d568c72e 34 fields · synced May 31, 2026