DEVICE: VitalFlow Caddy (10850007732353)
Device Identifier (DI) Information
VitalFlow Caddy
58120
In Commercial Distribution
58120
MICHIGAN CRITICAL CARE CONSULTANTS, INC.
58120
In Commercial Distribution
58120
MICHIGAN CRITICAL CARE CONSULTANTS, INC.
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).
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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33317 | Cardiopulmonary bypass system centrifugal pump drive unit |
A mains electricity (AC-powered) device that powers and controls the speed of a disposable cardiovascular bypass system centrifugal pump, to which it is connected, for the circulation of blood through the extracorporeal circuit for gas exchange and reinfusion. This device drives the centrifugal rotor of the disposable centrifugal pump using magnetism.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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KRI | Accessory Equipment, Cardiopulmonary Bypass |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
d22084cf-4398-4459-bb72-97e3259fb214
September 27, 2024
1
September 19, 2024
September 27, 2024
1
September 19, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined