VitalFlow Motor Drive 58102

GUDID 10850007732254

Motor drive for the VitalFlow Centrifugal Pump

MICHIGAN CRITICAL CARE CONSULTANTS, INC.

Cardiopulmonary bypass system centrifugal pump drive unit

• Primary Device ID: 10850007732254
• NIH Device Record Key: f252779e-a779-4cc7-9990-d5d2fd3efe82
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VitalFlow Motor Drive
• Version Model Number: 58102
• Catalog Number: 58102
• 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: false
• 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	10850007732254 [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: 2024-09-27 Controller for VitalFlow Centrifugal Pump. The VitalFlow Console powers the VitalFlow motor drive unit which provides rotation
• 10850007732254 - VitalFlow Motor Drive: 2024-09-27Motor drive for the VitalFlow Centrifugal Pump
• 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