Thoratec® HeartMate® ICU Cover (1 Pack) - ICU Cover - Thoratec Corporation

Duns Number:070156955

Device Description: ICU Cover

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More Product Details

Catalog Number

10003491

Brand Name

Thoratec® HeartMate® ICU Cover (1 Pack)

Version/Model Number

10003491

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

DSQ

Product Code Name

Ventricular (Assisst) Bypass

Device Record Status

Public Device Record Key

b6498b5e-1d8d-45ad-94f8-0f8a8793dde3

Public Version Date

April 21, 2021

Public Version Number

10

DI Record Publish Date

June 26, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"THORATEC CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 18
3 A medical device with high risk that requires premarket approval 156