VitalFlow Caddy 58120

GUDID 10850007732353

The VitalFlow Caddy is a holder for the VitalFlow motor drive (Model 58102), VitalFlow emergency handcrank (Model 58103), and Nautilus™ VF ECMO oxygenator with Balance™ Biosurface (Model 58110).

MICHIGAN CRITICAL CARE CONSULTANTS, INC.

Cardiopulmonary bypass system centrifugal pump drive unit

• Primary Device ID: 10850007732353
• NIH Device Record Key: d22084cf-4398-4459-bb72-97e3259fb214
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VitalFlow Caddy
• Version Model Number: 58120
• Catalog Number: 58120
• Company DUNS: 806687406
• Company Name: MICHIGAN CRITICAL CARE CONSULTANTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• 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	10850007732353 [Primary]

FDA Product Code

• KRI: Accessory Equipment, Cardiopulmonary Bypass

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: 2024-09-27 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