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Dover

FDA UDI

Class I (US FDA UDI)

by Cardinal Health 200, LLC

Identity

Trade Name
Dover FDA UDI
Generic Name
Wearable adult urine collection bag, open-ended FDA UDI
Device Name
URINE LEG BAG, A/R VALVE, TWIST VALVE, LF LEG STRAPS, LARGE, 25 OZ. (730 ML) FDA UDI
Model / Reference
145516 FDA UDI
Description
URINE LEG BAG, A/R VALVE, TWIST VALVE, LF LEG STRAPS, LARGE, 25 OZ. (730 ML) FDA UDI

Identifiers

Catalog Number
145516 FDA UDI
Primary DI / UDI-DI
10192253028669 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

Dimensions & Sizes

Size
Total Volume — 739 Milliliter FDA UDI

Category: Wearable adult urine collection bag, open-ended

Dover by Cardinal Health 200, LLC — 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
Cardinal Health 200, LLC

Sources (1)

  • FDA UDI 8231046a-ea75-4744-a331-857c492e67a5 36 fields · synced Jun 8, 2026