TRUMPET

Basic Information

• Brand Name: TRUMPET
• Primary DI: 08054187380556
• Version / Model: TRUMPET REM
• Catalog Number: 10866
• Company Name: INVENTIS SRL
• Labeler DUNS: 338454995
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-17
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: da99f010-adda-4d0c-90a8-b876d4d6602e

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

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ETW	Calibrator, Hearing Aid / Earphone And Analysis Systems	Ear, Nose, Throat	874.3310	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08054187380556	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]