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Cardinal Health

FDA UDI

Class I (US FDA UDI)

by Cardinal Health 200, LLC

Identity

Trade Name
CARDINAL HEALTH FDA UDI
Generic Name
Wearable adult urine collection bag, closed-ended FDA UDI
Device Name
Premium Leg Bag 500ml; Flocked Back; Flip Valve; Pre-attached Fabric Leg Straps; Sterile Fluid Pathways FDA UDI
Model / Reference
LB500H FDA UDI
Description
Premium Leg Bag 500ml; Flocked Back; Flip Valve; Pre-attached Fabric Leg Straps; Sterile Fluid Pathways FDA UDI

Identifiers

Catalog Number
LB500H FDA UDI
Primary DI / UDI-DI
10885380126352 FDA UDI
FDA Product Code
FAQ FDA UDI
GMDN Term
Wearable adult urine collection bag, closed-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, closed-ended

Cardinal Health 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, closed-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 166f30f0-d6f0-4ff8-8859-3dca2e9ceacb 34 fields · synced Jun 8, 2026