Medline

FDA UDI

Class II (US FDA UDI)

by Medline Industries, Inc.

Identity

Trade Name: Medline FDA UDI
Generic Name: Faecal incontinence collector, catheterization FDA UDI
Device Name: DRAINBAG,LOW BED,1200ML,LF FDA UDI
Model / Reference: DYND15215 FDA UDI
Description: DRAINBAG,LOW BED,1200ML,LF FDA UDI

Identifiers

Catalog Number: DYND15215 FDA UDI
Primary DI / UDI-DI: 10884389051474 FDA UDI
FDA Product Code: KNX FDA UDI
GMDN Term: Faecal incontinence collector, catheterization 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Faecal incontinence collector, catheterization

Medline by Medline Industries, Inc. — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Medline Industries, Inc.

Sources (1)

FDA UDI e6f6664d-e1f7-4282-9bf6-62f0f05c2a41 36 fields · synced May 30, 2026