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Medline

FDA UDI

Class II (US FDA UDI)

by Medline Industries, Inc.

Identity

Trade Name
Medline FDA UDI
Generic Name
Wearable adult urine collection bag, closed-ended FDA UDI
Device Name
BAG,LEG,FLIP-DRAIN SPOUT,MEDIUM,20 OZ FDA UDI
Model / Reference
URO5454 FDA UDI
Description
BAG,LEG,FLIP-DRAIN SPOUT,MEDIUM,20 OZ FDA UDI

Identifiers

Catalog Number
URO5454 FDA UDI
Primary DI / UDI-DI
10888277410008 FDA UDI
FDA Product Code
KNX FDA UDI
GMDN Term
Wearable adult urine collection bag, closed-ended FDA UDI

Classification

Device Class
Class II 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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Wearable adult urine collection bag, closed-ended

Medline by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medline Industries, Inc.

Sources (1)

  • FDA UDI a9add52f-5297-4e5f-84b0-6627a7efdf56 35 fields · synced May 30, 2026