CentriMag™ - Pressure Cable for BD DTX Plus Transducer - Thoratec Switzerland GmbH

Duns Number:486066918

Device Description: Pressure Cable for BD DTX Plus Transducer

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More Product Details

Catalog Number

201-50110

Brand Name

CentriMag™

Version/Model Number

201-50110

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)

-

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

KRI

Product Code Name

ACCESSORY EQUIPMENT, CARDIOPULMONARY BYPASS

Device Record Status

Public Device Record Key

e7a33794-15f3-4573-9fb9-f73273e3317b

Public Version Date

April 06, 2022

Public Version Number

1

DI Record Publish Date

March 29, 2022

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