Catalog Number

66020794

Brand Name

RENASYS F SMALL W/SOFT PORT

Version/Model Number

66020794

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K142979,K142979

Product Code

OMP

Product Code Name

Negative Pressure Wound Therapy Powered Suction Pump

Public Device Record Key

4ac67877-9b1d-430b-86d2-cb49639cb422

Public Version Date

November 29, 2021

Public Version Number

2

DI Record Publish Date

April 24, 2020

Package DI Number

30040565127164

Quantity per Package

5

Contains DI Package

00040565127163

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case