Identity
- Trade Name
- Vivid FDA UDI
- Generic Name
- Cardiovascular ultrasound imaging system FDA UDI
- Device Name
- Vivid E9 XDclear Upgrade FDA UDI
- Model / Reference
- E9 BT11 and BT12 to BT13 XDclear UPG FDA UDI
- Description
- Vivid E9 XDclear Upgrade FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682121101 FDA UDI
- FDA Product Code
- IYO FDA UDIITX FDA UDIIYN FDA UDI
- GMDN Term
- Cardiovascular ultrasound imaging system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1560 FDA UDI892.1570 FDA UDI892.1550 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Vivid by Ge Vingmed Ultrasound — 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
- Ge Vingmed Ultrasound
Sources (1)
- FDA UDI 02d3e812-6f15-477b-bdcb-a9311dfbab74 35 fields · synced May 30, 2026