AccessGUDID - DEVICE: TRUMPET (08054187380556)

GUDID

Device Identifier (DI) Information

Brand Name: TRUMPET
Version or Model: TRUMPET REM
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10866
Company Name: INVENTIS SRL

Primary DI Number: 08054187380556
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 338454995 *Terms of Use

Device Description: Trumpet REM is a Real Ear Measurement (REM) system capable of assessing all the in-situ parameters required for a complete hearing aid fitting process.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36909	Ear canal insertion gain measurement instrument	A device that measures the sound pressure level in the ear canal. It is used in the fitting of hearing aids, comparing the results with and without the aid.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
ETW	Calibrator, Hearing Aid / Earphone And Analysis Systems

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: da99f010-adda-4d0c-90a8-b876d4d6602e
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 17, 2016