DiamondTemp™ Irrigation Tubing Set
FDA UDIEUDAMEDClass III (US FDA UDI)
Identity
- Trade Name
- DiamondTemp™ Irrigation Tubing Set FDA UDI
- Generic Name
- Cardiac ablation system irrigation tubing set FDA UDI
- Device Name
- Tubing Set EUDAMEDTUBING SET CEDTTS100 5PK US FDA UDI
- Model / Reference
- AFR-00002 EUDAMEDCEDTTS100 FDA UDI
- Description
- TUBING SET CEDTTS100 5PK US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000994990 EUDAMED00763000482169 FDA UDI
- Basic UDI-DI
- 0763000B000262386 EUDAMED
- PMA Number
- P200028 FDA UDI
- FDA Product Code
- OAE FDA UDI
- EMDN Code
- A060102 SURGICAL DRAINAGE CONNECTION MEDICAL TUBES EUDAMED
- GMDN Term
- Cardiac ablation system irrigation tubing set FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass III FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Cardiac ablation system irrigation tubing set
DiamondTemp™ Irrigation Tubing Set by Medtronic, Inc. — Class III — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Cardiac ablation system irrigation tubing set.
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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 (2 countries)
Regulatory Authorizations
MDR
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 |
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Manufacturer
- Manufacturer
- Medtronic, Inc.
Sources (2)
- FDA UDI f2d334a6-b5ab-49c6-86f1-8fefcd71c40b 36 fields · synced Jul 25, 2026
- EUDAMED 57e17256-46bb-4a07-83fb-26abda0639e5 61 fields · synced Jul 25, 2026