VitalFlow Console

FDA UDI

Class II (US FDA UDI)

by Michigan Critical Care Consultants, Inc.

Identity

Trade Name: VitalFlow Console FDA UDI
Generic Name: Cardiopulmonary bypass system centrifugal pump drive unit FDA UDI
Device Name: 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. FDA UDI
Model / Reference: 58100 FDA UDI
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. FDA UDI

Identifiers

Catalog Number: 58100 FDA UDI
Primary DI / UDI-DI: 10850007732247 FDA UDI
510(k) Number: K230364 FDA UDI
FDA Product Code: QNR FDA UDI
GMDN Term: Cardiopulmonary bypass system centrifugal pump drive unit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.4100 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Cardiopulmonary bypass system centrifugal pump drive unit

VitalFlow Console by Michigan Critical Care Consultants, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Bio-Console® — MEDTRONIC, INC. · Class II
Anivia SG1000 Pump Console — Asia Pacific Medical Technology Development Company Limited · Class II
Anivia SG1000 Pump Console — Apmtd, Inc. · Class II
Bio-Console® — MEDTRONIC, INC. · Class II
Sarns™ Centrifugal System — Terumo Cardiovascular Systems Corporation · Class II
Anivia SG1000 Pump Console — Apmtd, Inc. · Class II
INSPIRA ART100 — Inspira Technologies Oxy B.H.N. , Ltd. · Class II
Terumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems Corporation · Class II

Cleared under the same submission

K230364 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Michigan Critical Care Consultants, Inc.

Sources (1)

FDA UDI 5f450da0-aebc-4f4f-b10f-f8ef946afa74 35 fields · synced May 30, 2026

VitalFlow Console

Identity

Identifiers

Classification

Clinical & Handling

Similar devices

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

Manufacturer

Sources (1)