Catalog Number

-

Brand Name

Invia Foam Dressing Kit

Version/Model Number

200.8908

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

K170088,K170088

Product Code

OMP

Product Code Name

Negative Pressure Wound Therapy Powered Suction Pump

Public Device Record Key

66deab96-bedd-4ee2-afaa-9731133cf37f

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

June 07, 2017

Package DI Number

07612367050135

Quantity per Package

3

Contains DI Package

07612367050128

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-