Home GUDID 05711117229783 Sanibel Supply
Primary DI 05711117229783
Brand Sanibel Supply
Company Interacoustics A/S
Model TM electrode for ECochG, starter kit
Catalog number 8013209
Device description Medical device accessories intended for ABR measurements
Published 2022-12-29
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Product Codes# Code, Name table Code Name GWJ Stimulator, Auditory, Evoked Response
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GWJ Stimulator, Auditory, Evoked Response Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05711117229783 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05711117229783 05711117229783 5711117229783
GMDN Terms# Term, Definition table Term Definition Evoked-potential audiometer An electroacoustic instrument designed to evaluate the activity of the auditory pathway of the brain in response to an acoustic signal [auditory brainstem response (ABR)] it provides at the ear (e.g., clicks delivered through an earphone), without need of patient cooperation. The signal, detected via the device's scalp electrodes and possibly a reference electrode on the ear lobe, is measured using computer averaging and signal processing techniques. This device is typically used to assess the function of the auditory pathways and to differentiate coma due to metabolic factors from structural damage.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Humidity 60 Percent (%) Relative Humidity 70 Percent (%) Relative Humidity Storage Environment Temperature 10 Degrees Celsius 27 Degrees Celsius Storage Environment Temperature 60 Degrees Fahrenheit 80 Degrees Fahrenheit
Regulatory Flags# DUNS number 306308354 Device count 1 Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 05711117230796 Sanibel Supply A/S Sanibel EARturtle Universal 8537206 2026-05-14 05711117230802 Sanibel Supply A/S Sanibel EARturtle Universal Box of 36 kits w/tab e 8537209 2026-05-14 05711117244304 Sanibel Supply A/S Sanibel EARturtle Universal Box of 36 kits w/snap 8602500 2026-05-14 05711117244991 Interacoustics VisualEyes 505 2025-08-14 05711117245004 Interacoustics VisualEyes EyeSeeCam vHIT 2025-08-14 05711117245028 Interacoustics VisualEyes 525 2025-08-14 05711117230833 Sanibel Supply A/S ER10C-03 8537238 2025-08-07 05711117230840 Sanibel Supply A/S ER10C-04 8537239 2025-08-07 05711117230857 Sanibel Supply A/S ER10C-05 8537240 2025-08-07 05711117230864 Sanibel Supply A/S ER10C-06 8537241 2025-08-07 05711117245097 Sanibel Supply A/S ER10C-03 8537238 2025-08-07 05711117245103 Sanibel Supply A/S ER10C-04 8537239 2025-08-07 05711117245110 Sanibel Supply A/S ER10C-05 8537240 2025-08-07 05711117245127 Sanibel Supply A/S ER10C-06 8537241 2025-08-07 05711117008395 Sanibel Supply Ear tip, OAE-4 ER Infant, 4 mm red flanged 2022-12-08 05711117226089 Sanibel Supply Ear tip infant 4 mm, ANA-4.0, blue 2022-12-08 05711117226096 Sanibel Supply Ear tip infant 5 mm, ANA-5.0, green 2022-12-08 05711117226102 Sanibel Supply Ear tip infant 4,5 mm, ANA-4.5, red-brown 2022-12-08 05711117226119 Sanibel Supply Ear tip 5 mm, AOT-5.0 light blue 2022-12-08 05711117226126 Sanibel Supply Ear tip 4 mm, AOT-4.0 green 2022-12-08
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