LifeSPARC - Blood pump controller, charging station, Power - CARDIACASSIST, INC.

Duns Number:948683941

Device Description: Blood pump controller, charging station, Power cord, flow sensor, removable batteries

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More Product Details

Catalog Number

-

Brand Name

LifeSPARC

Version/Model Number

5900-0000

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

K183623

Product Code Details

Product Code

DWA

Product Code Name

Control, Pump Speed, Cardiopulmonary Bypass

Device Record Status

Public Device Record Key

87dc4a70-f0ee-4da3-95bb-a51a653fbce9

Public Version Date

December 26, 2019

Public Version Number

1

DI Record Publish Date

December 18, 2019

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