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AMSure® Urinary Leg Bag

FDA UDI

Class I (US FDA UDI)

by Amsino International, Inc.

Identity

Trade Name
AMSure® Urinary Leg Bag FDA UDI
Generic Name
Wearable adult urine collection bag, open-ended FDA UDI
Device Name
AMSure® Urinary Leg Bag Medium - 600 mL, Flip valve CONTENTS: One each 600 mL Urinary Leg Bag equipped with: Flip valve drainage bag, Anti-reflux Valve, Two Latex-Free Straps FDA UDI
Model / Reference
1 FDA UDI
Description
AMSure® Urinary Leg Bag Medium - 600 mL, Flip valve CONTENTS: One each 600 mL Urinary Leg Bag equipped with: Flip valve drainage bag, Anti-reflux Valve, Two Latex-Free Straps FDA UDI

Identifiers

Catalog Number
AS308F FDA UDI
Primary DI / UDI-DI
10704411008255 FDA UDI
FDA Product Code
FAQ FDA UDI
GMDN Term
Wearable adult urine collection bag, open-ended FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
876.5250 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Wearable adult urine collection bag, open-ended

AMSure® Urinary Leg Bag by Amsino International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Wearable adult urine collection bag, open-ended.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Amsino International, Inc.

Sources (1)

  • FDA UDI 4e9b4f58-07a6-40ad-94c9-e73248741da3 34 fields · synced Jun 8, 2026