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Avelle

FDA UDI

Class II (US FDA UDI)

by Convatec, Purchasing Department

Identity

Trade Name
AVELLE FDA UDI
Generic Name
Negative-pressure wound therapy system pump, electric FDA UDI
Device Name
AVELLE NPWT PUMP X6 BATTERY PACK NAI FDA UDI
Model / Reference
422285 FDA UDI
Description
AVELLE NPWT PUMP X6 BATTERY PACK NAI FDA UDI

Identifiers

Primary DI / UDI-DI
00768455155033 FDA UDI
510(k) Number
K180205 FDA UDI
FDA Product Code
OMP FDA UDI
GMDN Term
Negative-pressure wound therapy system pump, electric 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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Negative-pressure wound therapy system pump, electric

Avelle by Convatec, Purchasing Department — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Negative-pressure wound therapy system pump, electric.

Cleared under the same submission

K180205 also covers:

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 10161fc3-32e3-4406-af21-b1a8133b224a 35 fields · synced May 30, 2026