CENTRIMAG® 34FR DRAINAGE (VENOUS) CANNULA KIT - 34FR DRAINAGE (VENOUS) CANNULA KIT - Thoratec Switzerland GmbH

Duns Number:486066918

Device Description: 34FR DRAINAGE (VENOUS) CANNULA KIT

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More Product Details

Catalog Number

201-50067

Brand Name

CENTRIMAG® 34FR DRAINAGE (VENOUS) CANNULA KIT

Version/Model Number

201-50067

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

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

-

Product Code Details

Product Code

DWF

Product Code Name

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Device Record Status

Public Device Record Key

9c82ad5c-a52a-464f-b511-3ec00cf210a9

Public Version Date

August 05, 2022

Public Version Number

6

DI Record Publish Date

September 20, 2014

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"THORATEC SWITZERLAND GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 14
2 A medical device with a moderate to high risk that requires special controls. 29