Catalog Number

66800603

Brand Name

RENASYS GO

Version/Model Number

66800603

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

K152163,K152163

Product Code

OMP

Product Code Name

Negative Pressure Wound Therapy Powered Suction Pump

Public Device Record Key

1b37d59b-d045-40b8-bbac-bc44eb79e8b7

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 08, 2016

Package DI Number

30040565125290

Quantity per Package

20

Contains DI Package

00040565125299

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case