AccessGUDID - DEVICE: Quantum Perfusion Centrifugal Blood Pump CP20 (18051160302144)

GUDID

Device Identifier (DI) Information

Brand Name: Quantum Perfusion Centrifugal Blood Pump CP20
Version or Model: CP20V-V0U
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SPECTRUM MEDICAL SRL

Primary DI Number: 18051160302144
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 436188505 *Terms of Use

Device Description: No description.

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:	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?
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
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K220842	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: 1bc76cd0-b13b-4f11-ad54-8439d11528b8
Public Version Date: January 05, 2024
Public Version Number: 2
DI Record Publish Date: June 27, 2023