Catalog Number

66021814

Brand Name

RENASYS GO

Version/Model Number

66021814

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

79f9f0e3-6e5f-4f9d-8410-b783d1f5402e

Public Version Date

October 08, 2020

Public Version Number

4

DI Record Publish Date

December 01, 2016

Package DI Number

05000223491482

Quantity per Package

25

Contains DI Package

00040565125572

Package Discontinue Date

October 07, 2020

Package Status

Not in Commercial Distribution

Package Type

Case