TandemHeart- TRIS - 21 Fr x 62 cm venous cannula with dilator and - CARDIACASSIST, INC.

Duns Number:948683941

Device Description: 21 Fr x 62 cm venous cannula with dilator and introducer

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More Product Details

Catalog Number

-

Brand Name

TandemHeart- TRIS

Version/Model Number

5140-6221TRIS

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 13, 2015

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)

Yes

FDA Premarket Submission

K052570

Product Code Details

Product Code

DWF

Product Code Name

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Device Record Status

Public Device Record Key

e8671a6c-7712-4741-a905-32a05ad419ce

Public Version Date

October 03, 2018

Public Version Number

4

DI Record Publish Date

October 15, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CARDIACASSIST, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 37
2 A medical device with a moderate to high risk that requires special controls. 27