Catalog Number

66800934

Brand Name

RENaSYS G MEDIUM W/SOFT PORT

Version/Model Number

66800934

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

K162129,K162129

Product Code

OMP

Product Code Name

Negative Pressure Wound Therapy Powered Suction Pump

Public Device Record Key

4a9441f2-e3f3-4842-b8cc-28d1a62428fc

Public Version Date

May 25, 2020

Public Version Number

1

DI Record Publish Date

May 15, 2020

Package DI Number

30040565125726

Quantity per Package

5

Contains DI Package

00040565125725

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case