Duns Number:338454995
Device Description: Trumpet REM & AUD is- a Real Ear Measurement (REM) system capable of assessing all the in- Trumpet REM & AUD is- a Real Ear Measurement (REM) system capable of assessing all the in-situ parameters required for a complete hearing aid fitting process, and- a diagnostic audiometer capable of performing pure tone and speech audiometry, in air, free field, and in bone conduction.
Catalog Number
10969
Brand Name
TRUMPET
Version/Model Number
TRUMPET REM & AUD
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ETW
Product Code Name
Calibrator, Hearing Aid / Earphone And Analysis Systems
Public Device Record Key
51aa40f1-f082-4751-8352-b937c470a544
Public Version Date
March 29, 2018
Public Version Number
2
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 44 |