Identity
- Trade Name
- FloPump FDA UDI
- Generic Name
- Cardiopulmonary bypass system centrifugal pump FDA UDI
- Device Name
- The IBC FloPump is a single-use, disposable centrifugal blood pump intended for use only with the Medtronic Bio Medicus Bio-Console to pump blood through the extracorporeal bypass circuit during open heart surgery. FDA UDI
- Model / Reference
- FloPump/FloProbe Kit (Non-Sterile) FDA UDI
- Description
- The IBC FloPump is a single-use, disposable centrifugal blood pump intended for use only with the Medtronic Bio Medicus Bio-Console to pump blood through the extracorporeal bypass circuit during open heart surgery. FDA UDI
Identifiers
- Catalog Number
- 6000N(KIT) FDA UDI
- Primary DI / UDI-DI
- 00814321020452 FDA UDI
- 510(k) Number
- K983272 FDA UDI
- FDA Product Code
- KFM FDA UDI
- GMDN Term
- Cardiopulmonary bypass system centrifugal pump FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4360 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
Yes
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
FloPump 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 a49c1e7e-8268-4a1d-b494-394369a97729 36 fields · synced Jun 1, 2026