Identity
- Trade Name
- FORUM FDA UDI
- Generic Name
- Patient health record information system application software FDA UDI
- Device Name
- This database entry covers UDI for SW Versions 4.1 and higher: (01)04049471070026(10)411 -> Version 4.1.1; (01)04049471070026(10)420 -> Version 4.2; (01)04049471070026(10)421 -> Version 4.2.1; (01)04049471070026(10)423 -> Version 4.2.3; (01)04049471070026(10)424 -> Version 4.2.4, (01)04049471070026(10)425 -> Version 4.2.5, (01)04049471070026(10)426 -> Version 4.2.6 FDA UDI
- Model / Reference
- 4.1 FDA UDI
- Description
- This database entry covers UDI for SW Versions 4.1 and higher: (01)04049471070026(10)411 -> Version 4.1.1; (01)04049471070026(10)420 -> Version 4.2; (01)04049471070026(10)421 -> Version 4.2.1; (01)04049471070026(10)423 -> Version 4.2.3; (01)04049471070026(10)424 -> Version 4.2.4, (01)04049471070026(10)425 -> Version 4.2.5, (01)04049471070026(10)426 -> Version 4.2.6 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049471070026 FDA UDI
- FDA Product Code
- NFJ FDA UDI
- GMDN Term
- Patient health record information system application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Patient health record information system application software
Forum by Carl Zeiss Meditec AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Carl Zeiss Meditec AG
Sources (1)
- FDA UDI 491353d8-bf47-4543-9fbc-a4092fd82dc4 33 fields · synced May 30, 2026