Avantgarde

FDA UDI

Class II (US FDA UDI)

by Prosys International, Ltd.

Identity

Trade Name: AVANTGARDE FDA UDI
Generic Name: Faecal incontinence kit FDA UDI
Device Name: Fecal Management System FDA UDI
Model / Reference: AVG100+T FDA UDI
Description: Fecal Management System FDA UDI

Identifiers

Primary DI / UDI-DI: 05060182171894 FDA UDI
510(k) Number: K193325 FDA UDI
FDA Product Code: KNT FDA UDI
GMDN Term: Faecal incontinence kit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5980 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

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Faecal incontinence kit

Avantgarde by Prosys International, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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FLEXI-SEAL — CONVATEC, PURCHASING DEPARTMENT · Class II
Bard® DigniShield® Stool Management System — C. R. Bard, Inc. · Class II
Qora AIM Stool Management Kit — Consure Medical Private Limited · Class II

Cleared under the same submission

K193325 also covers:

AVANTGARDE — Prosys International, Ltd.

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: Prosys International, Ltd.

Sources (1)

FDA UDI 71ecf931-3919-4b88-bad5-6dc55eca3e1b 34 fields · synced May 30, 2026