FDA.reportPublic FDA data

Otoport/Otocheck Infection Control Sleeve

Primary DI
05060396170249
Brand
Otoport/Otocheck Infection Control Sleeve
Company
OTODYNAMICS LIMITED
Model
OP-INF
Published
2016-08-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
EWOAudiometer
GWJStimulator, Auditory, Evoked Response

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EWOAudiometerEar, Nose, Throat2
GWJStimulator, Auditory, Evoked ResponseNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060396170249PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060396170249050603961702495060396170249

GMDN Terms#

Term, Definition table
TermDefinition
Otoacoustic emission system, battery-poweredAn assembly of battery-powered devices designed to record and analyse the faint sounds hair cells in the inner ear emit [otoacoustic emission (OAE)] in response to a stimulus (e.g., click, tone burst, pure-tone signals) to test for a deficiency of function in the ear during diagnostic evaluation and/or neonatal screening. It typically consists of a portable programmable unit, an OAE probe, and eartips. The stimulus signal is emitted via the probe inserted into the ear canal and the response is recorded via a microphone in the probe; OAEs are absent/reduced in patients with hearing loss. The system may be combined with other audiological devices (e.g., tympanometer, ABR device).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
235908050
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060396171130Crib/bassinet device holster for OtoNovaNOVA-CRIB2024-08-20
05060396171512Tablet Computer for OtoNova Pro NOVA-TABLET2024-08-20
05060396171529OtoNova ChargerNOVA-CHG2024-08-20
05060396171536OtoNova Wireless Charging PadNOVA-CHG-PAD2024-08-20
05060396172243XPD Ear ProbePR-XPD2024-08-20
05060396172359ABR Electrode Cable (SNAP) for OtoNova ProNPRO-SEC2024-08-20
05060396172366ABR Electrode Cable (TAB) for OtoNova ProNPRO-TEC2024-08-20
05060396172809OtoNova Battery Assembly Service KitON-BATT-KIT2024-08-20
05060396173011OtoNova Pro OAE+AABR instrumentOTONOVAPRO2024-08-20
05060396173042OtoNova Pro Main PCB Service KitON2-MAIN2024-08-20
05060396173059OtoNova Pro Charger PCB Service KitON2-CHG-KIT2024-08-20
05060396173080OtoNova Pro Case Service KitON2-CASE-KIT2024-08-20
05060396173103OtoNova Pro Screener TENPRO-SCR-T2024-08-20
05060396173110OtoNova Pro Screener DPNPRO-SCR-D2024-08-20
05060396173127OtoNova Pro Screener AABRNPRO-SCR-A2024-08-20
05060396173134OtoNova Pro Screener DP+TENPRO-SCR-DT2024-08-20
05060396173141OtoNova Pro Screener TE+AABRNPRO-SCR-TA2024-08-20
05060396173158OtoNova Pro Screener DP+AABRNPRO-SCR-DA2024-08-20
05060396173165OtoNova Pro Screener DP+TE+AABRNPRO-SCR-DTA2024-08-20
05060396173172OtoNova Pro Clinical+TE+AABRNPRO-CLN-DTA2024-08-20

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Primary DI, Brand, Company table
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B43071000030GoCheck MultiScreenerGobiquity, Inc.EWO2025-11-19
08056446901106NExT-DOCKINGEB NEURO SPAGWJ2025-05-22
08056446901113NExT-PADEB NEURO SPAGWJ2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAGWJ2025-05-22
08056446901137NExT-HSEB NEURO SPAGWJ2025-05-22
08056446901168NExT-AMPEB NEURO SPAGWJ2025-05-22
08056446901199NExT-ASEB NEURO SPAGWJ2025-05-22
08056446901205NExT StationEB NEURO SPAGWJ2025-05-22
08056446901090NExT Station AdvancedEB NEURO SPAGWJ2025-05-19
15060753520004Tympa Otoscope SystemTYMPA HEALTH TECHNOLOGIES LIMITEDEWO2025-02-04
25060753520063Tympa CloudTYMPA HEALTH TECHNOLOGIES LIMITEDEWO2025-02-04
25060753520070Tympa Mobile AppTYMPA HEALTH TECHNOLOGIES LIMITEDEWO2025-02-04
B43071000020GoCheck MultiScreenerGobiquity, Inc.EWO2024-09-23
00817020021126AriaINTELLIGENT HEARING SYSTEMS CORP.EWO2024-03-11
00627908020192Bone ConductorVivosonic IncEWO2023-06-12
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00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyGWJ2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyGWJ2023-04-19
00195278524089NAGE Healthcare Finland OyGWJ2023-04-19
08054187380761TIMPANI DOCKING STATIONINVENTIS SRLEWO2023-01-04
00195278466662E-EEGXGE Healthcare Finland OyGWJ2022-07-01
00195278466679N-EEGXGE Healthcare Finland OyGWJ2022-07-01
08056446900642Galileo NT Line SoftwareEB NEURO SPAGWJ2020-05-25
00382830045247Echo-Screen III ProNATUS MEDICAL INCORPORATEDGWJ2020-02-20
00382830045278Echo-Screen III ProNATUS MEDICAL INCORPORATEDGWJ2020-02-20