Identity
- Trade Name
- DiamondTemp™ Irrigation Pump FDA UDI
- Generic Name
- Basic roller pump FDA UDI
- Device Name
- IRRIGATION PUMP CEDTP100 US/CAN FDA UDI
- Model / Reference
- CEDTP100 FDA UDI
- Description
- IRRIGATION PUMP CEDTP100 US/CAN FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000540616 FDA UDI
- PMA Number
- P200028 FDA UDI
- FDA Product Code
- OAE 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
DiamondTemp™ Irrigation Pump by Medtronic, Inc. — Class III — FDA UDI — listed in FDA GUDID — 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
- HexaFlow™ Irrigation Pump — MEDTRONIC, INC. · Class III
Cleared under the same submission
P200028 also covers:
- DiamondTemp™ EGM cable — MEDTRONIC NAVIGATION, INC.
- DiamondTemp™ Bidirectional Ablation Catheter — MEDTRONIC, INC.
- DiamondTemp™ Bidirectional Ablation Catheter — MEDTRONIC, INC.
- DiamondTemp™ Bidirectional Ablation Catheter — MEDTRONIC, INC.
- DiamondTemp™ Bidirectional Ablation Catheter — MEDTRONIC, INC.
- DiamondTemp™ Bidirectional Ablation Catheter — MEDTRONIC, INC.
- DiamondTemp™ Bidirectional Ablation Catheter — MEDTRONIC, INC.
- DiamondTemp™ Catheter-to-RFG Cable — MEDTRONIC, INC.
- DiamondTemp™ Catheter-to-RFG Cable — MEDTRONIC, INC.
- DiamondTemp™ FASTR RF Generator — MEDTRONIC, INC.
- DiamondTemp™ FASTR RF Generator — MEDTRONIC, INC.
- DiamondTemp™ FASTR RF Generator — MEDTRONIC, 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 III | Pending data |
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Manufacturer
- Manufacturer
- Medtronic, Inc.
Sources (1)
- FDA UDI f2dc727b-e878-40a1-b773-a5ad3f00421f 36 fields · synced May 30, 2026