Sarns™ Temperature Control Module - TCM II Cooling/Heating System - Terumo Cardiovascular Systems Corporation

Duns Number:177655466

Device Description: TCM II Cooling/Heating System

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More Product Details

Catalog Number

4415

Brand Name

Sarns™ Temperature Control Module

Version/Model Number

4415

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

DWC

Product Code Name

Controller, Temperature, Cardiopulmonary Bypass

Device Record Status

Public Device Record Key

35ef4f3f-c498-40b8-a275-dc9a6bbb71a8

Public Version Date

December 23, 2019

Public Version Number

5

DI Record Publish Date

September 24, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TERUMO CARDIOVASCULAR SYSTEMS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 36
2 A medical device with a moderate to high risk that requires special controls. 174