Catalog Number

66020936

Brand Name

RENASYS G X-LARGE W/SOFT PORT

Version/Model Number

66020936

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

4de38a6a-702e-4b66-ac0e-8fa67403c59c

Public Version Date

May 04, 2020

Public Version Number

1

DI Record Publish Date

April 24, 2020

Package DI Number

30040565127225

Quantity per Package

5

Contains DI Package

00040565127224

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case