Identity
- Trade Name
- VitalFlow Flow and Bubble Sensor, 2m FDA UDI
- Generic Name
- Cardiopulmonary bypass system centrifugal pump drive unit FDA UDI
- Device Name
- Flow and Bubble Sensor (2m) for VitalFlow Console FDA UDI
- Model / Reference
- 58150 FDA UDI
- Description
- Flow and Bubble Sensor (2m) for VitalFlow Console FDA UDI
Identifiers
- Catalog Number
- 58150 FDA UDI
- Primary DI / UDI-DI
- 10850007732278 FDA UDI
- 510(k) Number
- K230364 FDA UDI
- FDA Product Code
- QNR FDA UDI
- GMDN Term
- Cardiopulmonary bypass system centrifugal pump drive unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4100 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Cardiopulmonary bypass system centrifugal pump drive unit
VitalFlow Flow and Bubble Sensor, 2m by Michigan Critical Care Consultants, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K230364 also covers:
- VitalFlow Console — MICHIGAN CRITICAL CARE CONSULTANTS, INC.
- VitalFlow Emergency Handcrank — MICHIGAN CRITICAL CARE CONSULTANTS, INC.
- VitalFlow Motor Drive — MICHIGAN CRITICAL CARE CONSULTANTS, INC.
- VitalFlow Power Cord 12 V DC, 3m — MICHIGAN CRITICAL CARE CONSULTANTS, INC.
- VitalFlow Power Cord CEE 7/7, 2.5m — MICHIGAN CRITICAL CARE CONSULTANTS, INC.
- VitalFlow Power Cord NEMA-5-15, 3m — MICHIGAN CRITICAL CARE CONSULTANTS, INC.
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 II | Pending data |
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Manufacturer
- Manufacturer
- Michigan Critical Care Consultants, Inc.
Sources (1)
- FDA UDI 0fea782c-50a4-42de-afd0-62123ac497f3 35 fields · synced Jun 1, 2026