Cardinal Health

FDA UDI

Class I (US FDA UDI)

by Cardinal Health 200, LLC

Identity

Trade Name: CARDINAL HEALTH FDA UDI
Generic Name: Urinary catheter holder FDA UDI
Device Name: Cardinal Health; Foley Catheter Holder Leg Band; Velcro Locking System; Non Adhesive; 2 in. wide; Fits up to 60 in.; Extra Large; Disposable FDA UDI
Model / Reference: FLB60 FDA UDI
Description: Cardinal Health; Foley Catheter Holder Leg Band; Velcro Locking System; Non Adhesive; 2 in. wide; Fits up to 60 in.; Extra Large; Disposable FDA UDI

Identifiers

Catalog Number: FLB60 FDA UDI
Primary DI / UDI-DI: 10885380100314 FDA UDI
FDA Product Code: EYJ FDA UDI
GMDN Term: Urinary catheter holder FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 876.5130 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Urinary catheter holder

Cardinal Health by Cardinal Health 200, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Cardinal Health 200, LLC

Sources (1)

FDA UDI 495a1f26-17ef-4d2e-a74a-44b5f4915f87 34 fields · synced Jun 8, 2026