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Flexi-Seal

FDA UDI

Class I (US FDA UDI)

by Convatec, Purchasing Department

Identity

Trade Name
FLEXI-SEAL FDA UDI
Generic Name
Faecal incontinence collector, catheterization FDA UDI
Device Name
Flexi-Seal™ Privacy FMS Collection Bags With Filter For Protect Plus Only FDA UDI
Model / Reference
422291 FDA UDI
Description
Flexi-Seal™ Privacy FMS Collection Bags With Filter For Protect Plus Only FDA UDI

Identifiers

Primary DI / UDI-DI
00768455207114 FDA UDI
FDA Product Code
EZQ 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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: Faecal incontinence collector, catheterization

Flexi-Seal by Convatec, Purchasing Department — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Faecal incontinence collector, catheterization.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Convatec, Purchasing Department

Sources (1)

  • FDA UDI 8e02bb22-7f9b-4c12-bc80-83ab4925bf1f 34 fields · synced May 29, 2026