ExtriCARE

FDA UDI

Class II (US FDA UDI)

by Alleva Medical, Ltd.

Identity

Trade Name: ExtriCARE FDA UDI
Generic Name: Negative-pressure wound therapy system drape FDA UDI
Device Name: Negative Pressure Wound Therapy Drape - 33.5x32cm FDA UDI
Model / Reference: ST403-0001 FDA UDI
Description: Negative Pressure Wound Therapy Drape - 33.5x32cm FDA UDI

Identifiers

Catalog Number: EC-DRAPE FDA UDI
Primary DI / UDI-DI: 04897089070217 FDA UDI
510(k) Number: K140634 FDA UDI
FDA Product Code: OMP FDA UDI
GMDN Term: Negative-pressure wound therapy system drape FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4780 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Category: Negative-pressure wound therapy system drape

ExtriCARE by Alleva Medical, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Negative-pressure wound therapy system drape.

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WoundPro Outer Drape — Pensar Medical, LLC · Class II
V.A.C. DERMATAC™ — KCI USA, INC. · Class II
WoundPro Outer Drape, — Pensar Medical, LLC · Class II
Avance® — Mölnlycke Health Care AB · Class II
XLR8 Transparent Film Dressing — GENADYNE BIOTECHNOLOGIES, INC. · Class II
Avance — Mölnlycke Health Care AB · Class II

Cleared under the same submission

K140634 also covers:

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: Alleva Medical, Ltd.

Sources (1)

FDA UDI 6bb77d49-643f-4d94-85de-d94628f93e5a 35 fields · synced Jun 8, 2026