Catalog Number

66020914

Brand Name

RENASYS GO

Version/Model Number

66020914

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

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

K152163,K152163

Product Code

OMP

Product Code Name

Negative Pressure Wound Therapy Powered Suction Pump

Public Device Record Key

22334773-7cb5-4b44-8804-0c47206e2a55

Public Version Date

November 23, 2021

Public Version Number

4

DI Record Publish Date

December 02, 2016

Package DI Number

30040565127324

Quantity per Package

5

Contains DI Package

00040565127323

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case