Identity
- Trade Name
- Aurix Software FDA UDI
- Generic Name
- Evoked-potential audiometer FDA UDI
- Device Name
- Aurix software for use with the Aurix system (DI: 00627908080011) The UDI for software is comprised of the following: GTIN + Additional Product Identification Assigned by the Manufacturer (ADDITIONAL ID) (which represents the software version) UDI Application Identifier for Additional Product Identification Assigned by the Manufacturer (ADDITIONAL ID) = 240 FDA UDI
- Model / Reference
- SWA002 FDA UDI
- Description
- Aurix software for use with the Aurix system (DI: 00627908080011) The UDI for software is comprised of the following: GTIN + Additional Product Identification Assigned by the Manufacturer (ADDITIONAL ID) (which represents the software version) UDI Application Identifier for Additional Product Identification Assigned by the Manufacturer (ADDITIONAL ID) = 240 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00627908090027 FDA UDI
- FDA Product Code
- GWJ FDA UDI
- GMDN Term
- Evoked-potential audiometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1900 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
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Aurix Software by Vivosonic Inc — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Vivosonic Inc
Sources (1)
- FDA UDI 3b4f1511-457f-4f8a-acdb-1f7f90fb8321 34 fields · synced May 30, 2026