AccessGUDID - DEVICE: VitalFlow Centrifugal Pump (10850007732346)

GUDID

Device Identifier (DI) Information

Brand Name: VitalFlow Centrifugal Pump
Version or Model: 58111
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 58111
Company Name: MICHIGAN CRITICAL CARE CONSULTANTS, INC.

Primary DI Number: 10850007732346
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 806687406 *Terms of Use

Device Description: The VitalFlow Centrifugal Pump is a blood pump designed to move blood by centrifugal force generated by a combination of a smooth rotating cone and low-profile impeller fins. Energy is transferred from the pump in the form of pressure and velocity as the blood is driven toward the outlet port of the pump. To limit friction and heat generation, the VitalFlow Centrifugal Pump utilizes a pivot bearing design on a dual ceramic pivot. The pump’s blood contacting surface is coated with Balance Biosurface which is a non-heparin biocompatible coating that reduces platelet adhesion. The VitalFlow Centrifugal Pump couples to a remote magnetic drive unit called the VitalFlow™ Motor Drive, which interfaces with a pump speed controller. It also couples with the VitalFlow™ Emergency Hand Crank in the event of controller or power failure.

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":	No
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
QNR	Blood Pump For Ecmo, Long-Term (> 6 Hours) Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K223898	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: 590a6c50-d8cb-4cbe-8228-37cacc78420c
Public Version Date: September 30, 2024
Public Version Number: 1
DI Record Publish Date: September 20, 2024