LifeSPARC - IV Pole Clamp for blood pump controller - CARDIACASSIST, INC.

Duns Number:948683941

Device Description: IV Pole Clamp for blood pump controller

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

5900-0012

Brand Name

LifeSPARC

Version/Model Number

5900-0012

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

78500342-d7f3-4a2b-9e8b-690ae140f24f

Public Version Date

May 18, 2022

Public Version Number

1

DI Record Publish Date

May 10, 2022

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