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AMSure® Urinary Drainage Bag

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref AS312

by Amsino International, Inc.

Identity

Trade Name
AMSure® Urinary Drainage Bag EUDAMEDFDA UDI
Generic Name
Non-wearable adult urine collection bag, open-ended FDA UDI
Device Name
Urine Bag EUDAMED
AMSure® Urinary Drainage Bag CONTENTS: One 2000mL drainage bag equipped with: T-valve drainage outlet, Air vent, Universal hanger, Sampling adapter, Anti-reflux drip chamber, Protective cap FDA UDI
Model / Reference
AS312 EUDAMED
1 FDA UDI
Description
AMSure® Urinary Drainage Bag CONTENTS: One 2000mL drainage bag equipped with: T-valve drainage outlet, Air vent, Universal hanger, Sampling adapter, Anti-reflux drip chamber, Protective cap FDA UDI

Identifiers

Catalog Number
AS312 FDA UDI
Primary DI / UDI-DI
10704411004103 EUDAMEDFDA UDI
Basic UDI-DI
B-10704411004103 EUDAMED
FDA Product Code
KNX FDA UDI
EMDN Code
A06030301 URINE COLLECTION BAGS EUDAMED
GMDN Term
Non-wearable adult urine collection bag, open-ended FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
876.5250 FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Amsino International, Inc.

Sources (2)

  • FDA UDI 2c17e581-ae4c-41cd-8337-f626ada8a234 34 fields · synced Oct 6, 2026
  • EUDAMED e514bbc7-6f24-4f54-b758-4f8d7b8dbe9d 61 fields · synced Jul 11, 2026