Catalog Number

-

Brand Name

Invia Foam Dressing Kit

Version/Model Number

200.8907

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,K170088

Product Code

OMP

Product Code Name

Negative Pressure Wound Therapy Powered Suction Pump

Public Device Record Key

c471ddd7-d605-40db-80f5-76769ce9cbd1

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

June 07, 2017

Package DI Number

07612367050111

Quantity per Package

15

Contains DI Package

07612367050098

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-