AccessGUDID - DEVICE: LifeSPARC (00814112020609)

GUDID

Device Identifier (DI) Information

Brand Name: LifeSPARC
Version or Model: 5800-1000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: CARDIACASSIST, INC.

Primary DI Number: 00814112020609
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: LifeSPARC Priming Tray Kit: LIfeSPARC Blood Pump with TandemLung Oxygenator

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
31718	Cardiopulmonary bypass system centrifugal pump	A device intended to be connected to a drive unit (not included) to circulate blood through the extracorporeal circuit of a non-roller type cardiopulmonary bypass system, via a centrifugal force mechanism, for gas exchange and reinfusion; it may in addition be used in extracorporeal support systems for ventricular support/circulatory assistance. It includes flow channels and a rotor driven by the system’s drive unit. This is a single-use device.	Active	false
17643	Extracorporeal membrane oxygenator	A device designed for the extracorporeal diffusion of oxygen into blood across a gas-permeable membrane during a cardiopulmonary bypass or extracorporeal membrane oxygenation procedure. It includes a membrane that separates a thin layer of blood from the oxygenating gas; oxygen diffuses from the gas compartment into the blood, while carbon dioxide diffuses from the blood through the membrane and is flushed out of the oxygenator by the oxygen flow. The device may include an integrated heat exchanger, arterial filter, or cardiotomy/venous reservoir. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KRI	Accessory Equipment, Cardiopulmonary Bypass
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
DTZ	Oxygenator, Cardiopulmonary Bypass

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K153295	000
K183623	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: 2e41ff5f-9cbf-4226-a0a5-10e4178f11d6
Public Version Date: December 11, 2024
Public Version Number: 2
DI Record Publish Date: May 29, 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: Yes
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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