Identity
- Trade Name
- JiveX FDA UDI
- Generic Name
- Radiological PACS software FDA UDI
- Device Name
- Version 5.2 includes all minor versions and patch levels of 5.2 FDA UDI
- Model / Reference
- 5.2 FDA UDI
- Description
- Version 5.2 includes all minor versions and patch levels of 5.2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260632470022 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Radiological PACS software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 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
No
FDA UDI
JiveX by VISUS Health IT GmbH — 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
- VISUS Health IT GmbH
Sources (1)
- FDA UDI 0be61d57-6738-4740-ad7c-dab441f8ae1f 35 fields · synced May 29, 2026