Catalog Number

-

Brand Name

Invia White Foam NPWT

Version/Model Number

087.6303

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K180415,K180415

Product Code

OMP

Product Code Name

Negative Pressure Wound Therapy Powered Suction Pump

Public Device Record Key

ece50a7a-70d6-45a2-8adc-968a77eaf8ed

Public Version Date

December 27, 2018

Public Version Number

1

DI Record Publish Date

November 26, 2018

Package DI Number

07612367057516

Quantity per Package

10

Contains DI Package

07612367057493

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-