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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, electric, reusable FDA UDI
Device Name
Extricare 3600 Negative Pressure Wound Therapy Pump FDA UDI
Model / Reference
MI390-0001 FDA UDI
Description
Extricare 3600 Negative Pressure Wound Therapy Pump FDA UDI

Identifiers

Catalog Number
EC3600 FDA UDI
Primary DI / UDI-DI
04897089070194 FDA UDI
510(k) Number
K140634 FDA UDI
FDA Product Code
OMP FDA UDI
GMDN Term
Negative-pressure wound therapy system, electric, reusable 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Negative-pressure wound therapy system, electric, reusable

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, electric, reusable.

Cleared under the same submission

K140634 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Alleva Medical, Ltd.

Sources (1)

  • FDA UDI cfff5486-e4bd-48e5-a8ff-be12e902b05a 35 fields · synced Jun 1, 2026