FDA.reportPublic FDA data

VitalFlow Console

Primary DI
10850007732247
Brand
VitalFlow Console
Company
MICHIGAN CRITICAL CARE CONSULTANTS, INC.
Model
58100
Catalog number
58100
Device description
Controller for VitalFlow Centrifugal Pump. The VitalFlow Console powers the VitalFlow motor drive unit which provides rotation of the VitalFlow Centrifugal pump. Pump motor speed (RPM) can be adjusted by the user and flow and bubble detection is provided by an ultrasonic flow probe and displayed on the touchscreen. The touchscreen display allows users to set alarm limits for all measured parameters. The device will alarm visually and audibly when limits are exceeded. Status indicators, power / battery life and secondary RPM indicator is provided. Data download and data streaming from the console is available for circuit data only; no patient data are stored or output.
Published
2024-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
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
K230364000
K250199000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230364000VitalFlow™ ConsoleMichigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.)2023-08-25QNR
K250199000VitalFlow ConsoleMedtronic, Inc.2025-05-20QNR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850007732247PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085000773224710850007732247

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass system centrifugal pump drive unitA mains electricity (AC-powered) device that powers and controls the speed of a disposable cardiovascular bypass system centrifugal pump, to which it is connected, for the circulation of blood through the extracorporeal circuit for gas exchange and reinfusion. This device drives the centrifugal rotor of the disposable centrifugal pump using magnetism.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
806687406
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
10850007732346VitalFlow Centrifugal Pump 58111581112024-09-20
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
10850007732346VitalFlow Centrifugal Pump MICHIGAN CRITICAL CARE CONSULTANTS, INC.QNR2024-09-20
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