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VitalFlow Set

FDA UDI

Class II (US FDA UDI)

by Michigan Critical Care Consultants, Inc.

Identity

Trade Name
VitalFlow Set FDA UDI
Generic Name
Cardiopulmonary bypass system blood tubing set FDA UDI
Device Name
The VitalFlow set contains components used to complete an extracorporeal circuit for ECMO procedures, including tubing assemblies, the Nautilus VF ECMO Oxygenator, and the VitalFlow Centrifugal Pump. The VitalFlow set contains a preassembled drainage and return loop “ECMO Circuit”, tubing assemblies, and other components used to prepare a basic extracorporeal circuit. The “Priming Circuit” contains components to supplement the basic extracorporeal circuit, as needed per hospital protocols for setting up the ECMO circuit. A venous reservoir and a one-way valve are included in the priming circuit to facilitate ease of priming the ECMO circuit. The Nautilus VF ECMO oxygenator with Balance Biosurface is used to oxygenate blood, remove carbon dioxide and regulate blood temperature. Blood enters the device and passes through both the heat exchange membrane, where temperature is adjusted, and the gas transfer membrane, where oxygen is added and carbon dioxide is removed. The VitalFlow Centrifugal Pump is 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. FDA UDI
Model / Reference
58112 FDA UDI
Description
The VitalFlow set contains components used to complete an extracorporeal circuit for ECMO procedures, including tubing assemblies, the Nautilus VF ECMO Oxygenator, and the VitalFlow Centrifugal Pump. The VitalFlow set contains a preassembled drainage and return loop “ECMO Circuit”, tubing assemblies, and other components used to prepare a basic extracorporeal circuit. The “Priming Circuit” contains components to supplement the basic extracorporeal circuit, as needed per hospital protocols for setting up the ECMO circuit. A venous reservoir and a one-way valve are included in the priming circuit to facilitate ease of priming the ECMO circuit. The Nautilus VF ECMO oxygenator with Balance Biosurface is used to oxygenate blood, remove carbon dioxide and regulate blood temperature. Blood enters the device and passes through both the heat exchange membrane, where temperature is adjusted, and the gas transfer membrane, where oxygen is added and carbon dioxide is removed. The VitalFlow Centrifugal Pump is 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. FDA UDI

Identifiers

Catalog Number
58112 FDA UDI
Primary DI / UDI-DI
10850007732339 FDA UDI
510(k) Number
K240880 FDA UDI
FDA Product Code
QJZ FDA UDI
GMDN Term
Cardiopulmonary bypass system blood tubing set 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Cardiopulmonary bypass system blood tubing setExtracorporeal membrane oxygenatorCardiopulmonary bypass system centrifugal pump

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

Similar devices

Also classified as Cardiopulmonary bypass system centrifugal pump.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Michigan Critical Care Consultants, Inc.

Sources (1)

  • FDA UDI 0811b2de-5c60-4b8c-8e6a-bd2b37bbc54d 35 fields · synced May 30, 2026