Main handheld unit for use with the Aurix system. The UDI is comprised of: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL) The following devices…
Main handheld unit for use with the Aurix system. The UDI is comprised of: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL) The following devices are accessories for use with the Aurix system: 11002 Sound Stimulator DI: 00627908080028 11003 Amplifier DI: 00627908080035 11010 Laptop Computer DI: 00627908080042 100116 Amplifier Lead Cable DI: 00627908080059 ER-3A-AUX Insert Earphones DI:00627908080066 100001 Electrodes DI: 00627908070067 100004 Ear Domes DI: 00627908080080 WA021 Tablet Computer DI: 00627908080097
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1), Shaanxi (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for Aurix Newborn Hearing Screening System | Listed by | Vivosonic Inc., Canada |
| FDA product code | GWJ |
| Device type | Stimulator, Auditory, Evoked Response |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1900 |
| Establishment | Manufacturer |
| Record published | 2016-09-23 |
| Record revised | 2020-04-21 (version 3) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2020-04-20 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.