FDA.reportPublic FDA data

FLUTE

Primary DI
08054187380440
Brand
FLUTE
Company
INVENTIS SRL
Model
FLUTE HF
Catalog number
10409
Device description
MIDDLE EAR ANALYZER.Flute HF is a middle ear analyzer, capable of performing: tympanometry and acoustic reflex tests in sequence and automatically, ETF (Eustachian Tube Function) test for both intact and perforated eardrums, and tympanometry at 1000 Hz.
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
PTOTester, Auditory Impedance, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PTOTester, Auditory Impedance, ExemptEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08054187380440PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08054187380440080541873804408054187380440

GMDN Terms#

Term, Definition table
TermDefinition
Impedance audiometerAn electronic instrument used to evaluate the functional condition of the middle ear by changing the air pressure in the external auditory canal to measure and graph the mobility characteristics of the tympanic membrane. It identifies abnormalities in tympanic membrane mobility due to stiffness, flaccidity, or the presence of fluid in the middle ear cavity. The device is also used to measure the acoustic reflex threshold from contractions of the stapedial muscle, to monitor healing of tympanic membrane grafts or stapedectomies, or to monitor follow up treatment for inflammation of the middle ear.

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
08054187381232easyTympINVENTIS SRLPTO2026-04-23
08054187381249easyTymp Docking StationINVENTIS SRLPTO2026-04-23
00860007953736WavelyDx Ear Tip - Pack of 3Wavely Diagnostics, Inc.PTO2026-04-03
00860007953767WavelyDx Middle Ear Fluid CMD iOS ApplicationWavely Diagnostics, Inc.PTO2026-04-03
00860007953774WavelyDx Ear Tip - Pack of 6Wavely Diagnostics, Inc.PTO2026-04-03
00860007953781WavelyDx Ear Tip - Pack of 2Wavely Diagnostics, Inc.PTO2026-04-03
08054187380761TIMPANI DOCKING STATIONINVENTIS SRLPTO2023-01-04
00860007953705Wavely Ear TipWavely Diagnostics, Inc.PTO2022-08-08
00860007953712WavelyDx Middle Ear Fluid CMD iOS ApplicationWavely Diagnostics, Inc.PTO2022-08-08
08054187380747TIMPANIINVENTIS SRLPTO2019-04-16
08054187380259FLUTEINVENTIS SRLPTO2016-09-17
08054187380266FLUTEINVENTIS SRLPTO2016-09-17
08054187380273FLUTEINVENTIS SRLPTO2016-09-17
08054187380280FLUTEINVENTIS SRLPTO2016-09-17
08054187380457FLUTEINVENTIS SRLPTO2016-09-17
08054187380464CLARINETINVENTIS SRLPTO2016-09-17
08054187380471CLARINETINVENTIS SRLPTO2016-09-17
08054187380488CLARINETINVENTIS SRLPTO2016-09-17
08054187380495CLARINETINVENTIS SRLPTO2016-09-17
08054187380402VIOLAINVENTIS SRLPTO2016-09-17
08054187380419VIOLAINVENTIS SRLPTO2016-09-17
08054187380426VIOLAINVENTIS SRLPTO2016-09-17
08054187380433VIOLAINVENTIS SRLPTO2016-09-17