← Back to catalogue

V.a.c. Simplicity™

FDA UDI

Class II (US FDA UDI)

by Kci Usa, Inc.

Identity

Trade Name
V.A.C. SIMPLICITY™ FDA UDI
Generic Name
Negative-pressure wound therapy system pump, electric FDA UDI
Device Name
VAC Simplicity Negative Pressure Wound Therapy Unit FDA UDI
Model / Reference
414063 FDA UDI
Description
VAC Simplicity Negative Pressure Wound Therapy Unit FDA UDI

Identifiers

Primary DI / UDI-DI
00849554003088 FDA UDI
510(k) Number
K111280 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

No

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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Negative-pressure wound therapy system pump, electric

V.a.c. Simplicity™ by Kci Usa, Inc. — 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

K111280 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Kci Usa, Inc.

Sources (1)

  • FDA UDI 2645c40c-9d94-403b-988c-28e212ad4e93 34 fields · synced Jun 1, 2026