AccessGUDID - DEVICE: LifeSPARC (00814112020593)

GUDID

Device Identifier (DI) Information

Brand Name: LifeSPARC
Version or Model: 5800-0000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: CARDIACASSIST, INC.

Primary DI Number: 00814112020593
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 blood pump kit with accessories

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?
36373	Cardiopulmonary bypass system mounting unit	A platform upon which modular devices of a cardiopulmonary bypass system (e.g., the blood pumps) are mounted to form the complete system. It typically includes electronics and control panels (e.g., microprocessors to control pump speed), and the main connection to the source of line power. It serves as the basic workstation for the operator to monitor and control the system's functions.	Active	false
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

FDA Product Code

[?]

Product Code	Product Code Name
KRI	Accessory Equipment, Cardiopulmonary Bypass
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
QNR	Blood Pump For Ecmo, Long-Term (> 6 Hours) Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: eebc2a4d-5c77-44ea-ad27-61d58a287aef
Public Version Date: December 11, 2024
Public Version Number: 4
DI Record Publish Date: December 18, 2019