VitalFlow Console 58100

GUDID 10850007732247

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.

MICHIGAN CRITICAL CARE CONSULTANTS, INC.

Cardiopulmonary bypass system centrifugal pump drive unit

• Primary Device ID: 10850007732247
• NIH Device Record Key: 5f450da0-aebc-4f4f-b10f-f8ef946afa74
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VitalFlow Console
• Version Model Number: 58100
• Catalog Number: 58100
• Company DUNS: 806687406
• Company Name: MICHIGAN CRITICAL CARE CONSULTANTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10850007732247 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230364

FDA Product Code

• QNR: Blood Pump For Ecmo, Long-Term (> 6 Hours) Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-27
• Device Publish Date: 2024-09-19

Devices Manufactured by MICHIGAN CRITICAL CARE CONSULTANTS, INC.

• 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 Console: 2024-09-27Controller 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.
• 10850007732247 - VitalFlow Console: 2024-09-27 Controller for VitalFlow Centrifugal Pump. The VitalFlow Console powers the VitalFlow motor drive unit which provides rotation
• 10850007732254 - VitalFlow Motor Drive: 2024-09-27 Motor drive for the VitalFlow Centrifugal Pump
• 10850007732261 - VitalFlow Emergency Handcrank: 2024-09-27 Emergency handcrank for the VitalFlow Centrifugal Pump
• 10850007732278 - VitalFlow Flow and Bubble Sensor, 2m: 2024-09-27 Flow and Bubble Sensor (2m) for VitalFlow Console
• 10850007732285 - VitalFlow Power Cord NEMA-5-15, 3m: 2024-09-27 AC Power Cord (US Type A, NEMA-5-15, 3m) for VitalFlow Console
• 10850007732292 - VitalFlow Power Cord CEE 7/7, 2.5m: 2024-09-27 AC Power Cord (EU Type F, CEE 7/7, 2.5m) for VitalFlow Console
• 10850007732308 - VitalFlow Power Cord 12 V DC, 3m: 2024-09-27 DC Power Cord (12 V DC, 3m) for VitalFlow Console