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FloProbe 3/8’’ x 3/8” (Non Sterile)
FDA UDIClass II (US FDA UDI)
by Movair, Inc.
Identity
- Trade Name
- FloProbe 3/8’’ x 3/8” (Non Sterile) FDA UDI
- Generic Name
- Electromagnetic blood flowmeter FDA UDI
- Device Name
- The brand name for this component is IBC FloProbe and is part of the AcuFlo system of products. This component is used in conjunction with the Medtronic Biomedicus Flow Pump System during open heart procedures. The IBC FloProbe is a direct product substitution for the Medtronic/Biomedicus Bioprobe, DP38. FDA UDI
- Model / Reference
- 3080N FDA UDI
- Description
- The brand name for this component is IBC FloProbe and is part of the AcuFlo system of products. This component is used in conjunction with the Medtronic Biomedicus Flow Pump System during open heart procedures. The IBC FloProbe is a direct product substitution for the Medtronic/Biomedicus Bioprobe, DP38. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10814321020176 FDA UDI
- 510(k) Number
- K963703 FDA UDI
- FDA Product Code
- DPT FDA UDI
- GMDN Term
- Electromagnetic blood flowmeter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2120 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
FloProbe 3/8’’ x 3/8” (Non Sterile) by Movair, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Movair, Inc.
Sources (1)
- FDA UDI 38c87b31-b8a3-4de7-915d-c4375df09b9c 35 fields · synced Jun 6, 2026