Identity
- Trade Name
- VitalFlow Caddy FDA UDI
- Generic Name
- Cardiopulmonary bypass system centrifugal pump drive unit FDA UDI
- Device Name
- 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). FDA UDI
- Model / Reference
- 58120 FDA UDI
- Description
- 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). FDA UDI
Identifiers
- Catalog Number
- 58120 FDA UDI
- Primary DI / UDI-DI
- 10850007732353 FDA UDI
- FDA Product Code
- KRI FDA UDI
- GMDN Term
- Cardiopulmonary bypass system centrifugal pump drive unit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 870.4200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cardiopulmonary bypass system centrifugal pump drive unit
VitalFlow Caddy by Michigan Critical Care Consultants, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Michigan Critical Care Consultants, Inc.
Sources (1)
- FDA UDI d22084cf-4398-4459-bb72-97e3259fb214 34 fields · synced May 29, 2026