Catalog Number

66801285

Brand Name

RENASYS TOUCH Class I Power Supply

Version/Model Number

66801285

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K153209,K153209

Product Code

OMP

Product Code Name

Negative Pressure Wound Therapy Powered Suction Pump

Public Device Record Key

e4ec7993-bb5c-4fa4-be84-0c28e443d004

Public Version Date

July 22, 2021

Public Version Number

2

DI Record Publish Date

May 17, 2021

Package DI Number

05000223495527

Quantity per Package

10

Contains DI Package

05000223495510

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case