Catalog Number

66020801

Brand Name

RENASYS® TOUCH

Version/Model Number

66020801

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

-

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

K181204,K181204

Product Code

OMP

Product Code Name

Negative Pressure Wound Therapy Powered Suction Pump

Public Device Record Key

e0842434-f05d-4d08-a4c0-5697431b4cf7

Public Version Date

April 20, 2021

Public Version Number

4

DI Record Publish Date

April 05, 2019

Package DI Number

05000223496173

Quantity per Package

100

Contains DI Package

05000223496296

Package Discontinue Date

October 01, 2020

Package Status

Not in Commercial Distribution

Package Type

Case