Medline

FDA UDI

Class I (US FDA UDI)

by Medline Industries, Inc.

Identity

Trade Name: MEDLINE FDA UDI
Generic Name: Faecal incontinence collector, catheterization FDA UDI
Device Name: REPLACEMENT BAG, FECAL MANAGEMENT, 40EA FDA UDI
Model / Reference: FMBAG01 FDA UDI
Description: REPLACEMENT BAG, FECAL MANAGEMENT, 40EA FDA UDI

Identifiers

Catalog Number: FMBAG01 FDA UDI
Primary DI / UDI-DI: 00888277728915 FDA UDI
FDA Product Code: EXB FDA UDI
GMDN Term: Faecal incontinence collector, catheterization FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 876.5900 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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: Faecal incontinence collector, catheterization

Medline by Medline Industries, Inc. — 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: Medline Industries, Inc.

Sources (1)

FDA UDI 1d8b2ee3-e8f2-4442-8c4f-64c5eb150703 35 fields · synced May 30, 2026