VitalFlow Centrifugal Pump 58111

GUDID 10850007732346

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.

MICHIGAN CRITICAL CARE CONSULTANTS, INC.

Cardiopulmonary bypass system centrifugal pump
Primary Device ID10850007732346
NIH Device Record Key590a6c50-d8cb-4cbe-8228-37cacc78420c
Commercial Distribution StatusIn Commercial Distribution
Brand NameVitalFlow Centrifugal Pump
Version Model Number58111
Catalog Number58111
Company DUNS806687406
Company NameMICHIGAN CRITICAL CARE CONSULTANTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110850007732346 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QNRBlood Pump For Ecmo, Long-Term (> 6 Hours) Use

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-30
Device Publish Date2024-09-20

Devices Manufactured by MICHIGAN CRITICAL CARE CONSULTANTS, INC.

10850007732346 - VitalFlow Centrifugal Pump 2024-09-30The 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.
10850007732346 - VitalFlow Centrifugal Pump 2024-09-30 The VitalFlow Centrifugal Pump is a blood pump designed to move blood by centrifugal force generated by a combination of a smoot
10850007732247 - VitalFlow Console2024-09-27 Controller for VitalFlow Centrifugal Pump. The VitalFlow Console powers the VitalFlow motor drive unit which provides rotation
10850007732254 - VitalFlow Motor Drive2024-09-27 Motor drive for the VitalFlow Centrifugal Pump
10850007732261 - VitalFlow Emergency Handcrank2024-09-27 Emergency handcrank for the VitalFlow Centrifugal Pump
10850007732278 - VitalFlow Flow and Bubble Sensor, 2m2024-09-27 Flow and Bubble Sensor (2m) for VitalFlow Console
10850007732285 - VitalFlow Power Cord NEMA-5-15, 3m2024-09-27 AC Power Cord (US Type A, NEMA-5-15, 3m) for VitalFlow Console
10850007732292 - VitalFlow Power Cord CEE 7/7, 2.5m2024-09-27 AC Power Cord (EU Type F, CEE 7/7, 2.5m) for VitalFlow Console
10850007732308 - VitalFlow Power Cord 12 V DC, 3m2024-09-27 DC Power Cord (12 V DC, 3m) for VitalFlow Console

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