Duns Number:198227881
Device Description: Welch Allyn OAE Hearing Screener; 100-240 V, 50-60 Hz AC, Lithium-Ion IEC Plug Type-B
Catalog Number
29400
Brand Name
Welch Allyn, Inc.
Version/Model Number
901031
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 10, 2018
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
EWO
Product Code Name
AUDIOMETER
Public Device Record Key
372c6617-95a9-4571-bd0f-14e154261afe
Public Version Date
May 10, 2021
Public Version Number
3
DI Record Publish Date
September 17, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 374 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4080 |
| 3 | A medical device with high risk that requires premarket approval | 1 |