AccessGUDID - DEVICE: LifeSPARC (00814112020630)

GUDID

Device Identifier (DI) Information

Brand Name: LifeSPARC
Version or Model: 5900-0002
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: CARDIACASSIST, INC.

Primary DI Number: 00814112020630
Issuing Agency: GS1
Commercial Distribution End Date: December 06, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 948683941 *Terms of Use

Device Description: Charging station for blood pump controller

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
33317	Cardiopulmonary bypass system centrifugal pump drive unit	A mains electricity (AC-powered) device that powers and controls the speed of a disposable cardiovascular bypass system centrifugal pump, to which it is connected, for the circulation of blood through the extracorporeal circuit for gas exchange and reinfusion. This device drives the centrifugal rotor of the disposable centrifugal pump using magnetism.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DWA	Control, Pump Speed, Cardiopulmonary Bypass
QNR	Blood Pump For Ecmo, Long-Term (> 6 Hours) Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K183623	000
K211830	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b59d6a10-9ee0-4912-968d-1dacf81a9510
Public Version Date: December 11, 2024
Public Version Number: 3
DI Record Publish Date: May 27, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 18003737421
Email: tl.regulatory@livanova.com

Phone: +14129637770
Email: tl.regulatory@livanova.com

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