Duns Number:201740425
Device Description: Main handheld unit for use with the Aurix system. The UDI is comprised of: GTIN + version 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: 0062790808002811003 Amplifier DI: 0062790808003511010 Laptop Computer DI: 00627908080042100116 Amplifier Lead Cable DI: 00627908080059ER-3A-AUX Insert Earphones DI:00627908080066100001 Electrodes DI: 00627908070067100004 Ear Domes DI: 00627908080080WA021 Tablet Computer DI: 00627908080097
Catalog Number
-
Brand Name
Aurix Newborn Hearing Screening System
Version/Model Number
AURIX-1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 20, 2020
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GWJ
Product Code Name
Stimulator, Auditory, Evoked Response
Public Device Record Key
decbcb6b-0530-4b07-8e54-1e31c472ae6f
Public Version Date
April 21, 2020
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 36 |