Catalog Number

66021206

Brand Name

RENASYS GO SERVICE MANUAL

Version/Model Number

66021206

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

67b305c2-880f-4094-a15f-6c3cea6970bd

Public Version Date

October 12, 2020

Public Version Number

1

DI Record Publish Date

October 02, 2020

Package DI Number

05000223491475

Quantity per Package

100

Contains DI Package

00040565127354

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case