Catalog Number

131078

Brand Name

Sarns™ Temperature Control Module

Version/Model Number

131078

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

K883603

Product Code

DWC

Product Code Name

Controller, Temperature, Cardiopulmonary Bypass

Public Device Record Key

41984f09-0f5a-4fc0-81ba-0907a137367e

Public Version Date

December 23, 2019

Public Version Number

5

DI Record Publish Date

February 08, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-