FDA.reportPublic FDA data

TRUMPET

Primary DI
08054187380556
Brand
TRUMPET
Company
INVENTIS SRL
Model
TRUMPET REM
Catalog number
10866
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.
Published
2016-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ETWCalibrator, Hearing Aid / Earphone And Analysis Systems

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETWCalibrator, Hearing Aid / Earphone And Analysis SystemsEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08054187380556PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08054187380556080541873805568054187380556

GMDN Terms#

Term, Definition table
TermDefinition
Ear canal insertion gain measurement instrumentA 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.

Contacts#

Phone, Email table
PhoneEmail
+39 0498962844sales@inventis.it

Regulatory Flags#

DUNS number
338454995
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08054187381232easyTympeasyTymp124672026-04-23
08054187381249easyTymp Docking StationeasyTymp Docking Station124682026-04-23
08054187380815Synapsys VHITSynapsys VHIT Basic107382025-01-08
08054187380822Synapsys VHITSynapsys VHIT Plus107392025-01-08
08054187380983VNGVNG BASIC WIRELESS114632024-10-01
08054187380990VNGVNG BASIC WIRELESS - XPR11463-XPR2024-10-01
08054187381003VNGVNG PLUS WIRELESS114642024-10-01
08054187381010VNGVNG PLUS WIRELESS - XPR 11464-XPR2024-10-01
08054187381027VNGVNG BASIC WIRED106192024-10-01
08054187381034VNGVNG PLUS WIRED106202024-10-01
08054187381041VNGVIDEO-SCOPE WIRELESS114472024-10-01
08054187381058VNGVIDEO-SCOPE WIRELESS - XPR11447-XPR2024-10-01
08054187381065VNGVIDEO-SCOPE WIRED119612024-10-01
08054187381140HARMONICAHARMONICA112052023-12-11
08054187380730DRUMDRUM112392017-08-24
08054187380020BELLBELL PLUS101442016-09-17
08054187380044HARPHARP BASIC101452016-09-17
08054187380051HARPHARP BASIC WITH PRINTER101622016-09-17
08054187380068HARPHARP PLUS101462016-09-17
08054187380075HARPHARP PLUS WITH PRINTER101632016-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05711781004297Measure by Otometrics - HITAuditdata A/SETW2025-11-14
05711781004372Measure by Otometrics - HITAuditdata A/SETW2025-11-14
05711781004006Unity 3Auditdata A/SETW2024-10-21
05711117244335Sanibel Supply A/SInteracoustics A/SETW2024-10-07
05711117228458Sanibel Supply A/SInteracoustics A/SETW2024-10-07
00810044583182MedRxMEDRX, INC.ETW2024-05-07
EADF03410600217207189audifonaudifon GmbH & Co. KGETW2023-03-31
05711117121742Sanibel Supply A/SInteracoustics A/SETW2022-12-29
05711117094206Sanibel Supply A/SInteracoustics A/SETW2022-12-29
05711117226478Sanibel Supply A/SInteracoustics A/SETW2022-12-29
05711117227550Sanibel Supply A/SInteracoustics A/SETW2022-11-29
05711117227574Sanibel Supply A/SInteracoustics A/SETW2022-11-29
05711117227581Sanibel Supply A/SInteracoustics A/SETW2022-11-29
05711117228557Sanibel Supply A/SInteracoustics A/SETW2022-11-29
05711117228564Sanibel Supply A/SInteracoustics A/SETW2022-11-29
05711117228571Sanibel Supply A/SInteracoustics A/SETW2022-11-29
EADF034106002172068681audifonaudifon GmbH & Co. KGETW2022-10-21
05713315009037NatusNatus Medical Denmark ApSETW2021-04-12
05713315009044NatusNatus Medical Denmark ApSETW2021-04-12
05713315009051NatusNatus Medical Denmark ApSETW2021-04-12
05713315008689NatusNatus Medical Denmark ApSETW2021-01-04
B161RE3670Audioscan Probe TubeEtymonic Design IncorporatedETW2020-01-15
05711117198218InteracousticsInteracoustics A/SETW2019-11-26
B161VA3000Verifit Skull SimulatorEtymonic Design IncorporatedETW2019-05-02
B161VA3003Verifit Skull SimulatorEtymonic Design IncorporatedETW2019-05-02
05713315005848GN Otometrics A/SNatus Medical Denmark ApSETW2019-04-24
05713315008184GN Otometrics A/SNatus Medical Denmark ApSETW2019-03-18
05713315005701GN Otometrics A/SNatus Medical Denmark ApSETW2018-11-06
05713315003301GN Otometrics A/SNatus Medical Denmark ApSETW2018-07-31
08054187380730DRUMINVENTIS SRLETW2017-08-24