Identity
- Trade Name
- HexaFlow™ Irrigation Pump FDA UDI
- Generic Name
- Basic roller pump FDA UDI
- Device Name
- IRRIGATION PUMP AFR-00005 HEXAFLOW US FDA UDI
- Model / Reference
- AFR-00005 FDA UDI
- Description
- IRRIGATION PUMP AFR-00005 HEXAFLOW US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000871895 FDA UDI
- PMA Number
- P240013 FDA UDI
- FDA Product Code
- OAE FDA UDIQZI FDA UDIOAD FDA UDI
- GMDN Term
- Basic roller pump FDA UDI
Classification
- Device Class
- Class III 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Basic roller pump
HexaFlow™ Irrigation Pump by Medtronic, Inc. — Class III — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Basic roller pump.
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- DiamondTemp™ Irrigation Pump — MEDTRONIC, INC. · Class III
- DiamondTemp™ Irrigation Pump — MEDTRONIC, INC. · Class III
Cleared under the same submission
P240013 also covers:
- HexaFlow™ Irrigation Pump — MEDTRONIC, INC.
- HexaGen™ RF Generator — MEDTRONIC, INC.
- HexaGen™ RF Generator — MEDTRONIC, INC.
- HexaPulse™ PF Generator — MEDTRONIC, INC.
- HexaPulse™ PF Generator — MEDTRONIC, INC.
- Sphere-9™ — MEDTRONIC, INC.
- Sphere-9™ Catheter — MEDTRONIC, INC.
- Sphere-9™ Catheter — MEDTRONIC, INC.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class III | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtronic, Inc.
Sources (2)
- FDA UDI 11dab6cf-ab43-4e16-a402-70dfafcf5c29 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 18, 2026