Identity
- Trade Name
- Itrevia 5 DR-T FDA UDI
- Generic Name
- Dual-chamber implantable defibrillator FDA UDI
- Model / Reference
- 392422 FDA UDI
Identifiers
- Catalog Number
- 392422 FDA UDI
- Primary DI / UDI-DI
- 04035479128906 FDA UDI
- FDA Product Code
- MRM FDA UDI
- GMDN Term
- Dual-chamber implantable defibrillator FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Itrevia 5 DR-T by BIOTRONIK SE & Co. KG — Class III — 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 III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BIOTRONIK SE & Co. KG
Sources (1)
- FDA UDI f8f787dc-8762-407b-88b7-e6ca9a6e1c7f 36 fields · synced May 30, 2026