FDA.reportPublic FDA data

VitalFlow Centrifugal Pump

Primary DI
10850007732346
Brand
VitalFlow Centrifugal Pump
Company
MICHIGAN CRITICAL CARE CONSULTANTS, INC.
Model
58111
Catalog number
58111
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.
Published
2024-09-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QNRBlood Pump For Ecmo, Long-Term (> 6 Hours) Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QNRBlood Pump For Ecmo, Long-Term (> 6 Hours) UseCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223898000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223898000VitalFlowTM Centrifugal PumpMichigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.)2023-08-25QNR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850007732346PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085000773234610850007732346

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
806687406
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850007732247VitalFlow Console58100581002024-09-19
10850007732421Nautilus VF Oxygenator Cable581302025-07-24
10850007732513MC3 Crescent RA Dual Lumen Catheter 13FR70413704132025-04-16
10850007732520MC3 Crescent RA Dual Lumen Catheter 15FR70415704152025-04-16
10850007732537MC3 Crescent RA Dual Lumen Catheter 19FR70419704192025-04-16
10850007732254VitalFlow Motor Drive58102581022024-09-19
10850007732261VitalFlow Emergency Handcrank58103581032024-09-19
10850007732278VitalFlow Flow and Bubble Sensor, 2m58150581502024-09-19
10850007732285VitalFlow Power Cord NEMA-5-15, 3m58131581312024-09-19
10850007732292VitalFlow Power Cord CEE 7/7, 2.5m58132581322024-09-19
10850007732308VitalFlow Power Cord 12 V DC, 3m58141581412024-09-19
10850007732315Nautilus VF ECMO Oxygentaor58110581102024-09-19
10850007732322Nautilus VF Oxygenator Cable58130481502024-09-19
10850007732339VitalFlow Set58112581122024-09-19
10850007732353VitalFlow Caddy58120581202024-09-19
10854916006406MC3494849482018-01-10
10854916006420MC3494949492018-01-10
10854916006444MC3495049502018-01-10
10854916006482MC3576157612018-01-10
10854916006505MC3576257622018-01-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850007732247VitalFlow ConsoleMICHIGAN CRITICAL CARE CONSULTANTS, INC.QNR2024-09-19
10850007732254VitalFlow Motor DriveMICHIGAN CRITICAL CARE CONSULTANTS, INC.QNR2024-09-19
10850007732261VitalFlow Emergency HandcrankMICHIGAN CRITICAL CARE CONSULTANTS, INC.QNR2024-09-19
10850007732278VitalFlow Flow and Bubble Sensor, 2mMICHIGAN CRITICAL CARE CONSULTANTS, INC.QNR2024-09-19
10850007732285VitalFlow Power Cord NEMA-5-15, 3mMICHIGAN CRITICAL CARE CONSULTANTS, INC.QNR2024-09-19
10850007732292VitalFlow Power Cord CEE 7/7, 2.5mMICHIGAN CRITICAL CARE CONSULTANTS, INC.QNR2024-09-19
10850007732308VitalFlow Power Cord 12 V DC, 3mMICHIGAN CRITICAL CARE CONSULTANTS, INC.QNR2024-09-19
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07640135140627CentriMag™Thoratec Switzerland GmbHQNR2014-09-20