Home GUDID 00197344013251 Medline
Primary DI 00197344013251
Brand Medline
Company MEDLINE INDUSTRIES, INC.
Model MDSHEARAIDBK2
Catalog number MDSHEARAIDBK2
Device description OTC, HEARING AID, IN EAR, BT, BLACK
Published 2023-11-28
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe
OTC true Product Codes# Code, Name table Code Name QUG Hearing Aid, Air-Conduction with Wireless Technology, Over the Counter
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QUG Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter Ear, Nose, Throat 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20197344013255 Package GS1 30 In Commercial Distribution 00197344013251 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 20197344013255 20197344013255 00197344013251 00197344013251 197344013251 0197344013251
GMDN Terms# Term, Definition table Term Definition Air-conduction hearing aid, in-the-ear A battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It typically consists of a miniature microphone, amplifier, and speaker (receiver) contained in a case that fits completely inside the outer ear (concha) [in-the-ear (ITE)]. The microphone receives sound waves and converts them into electrical signals which are increased by the amplifier and sent as sound waves, by the speaker, to the eardrum. The device is used for mild to severe hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 86 KiloPascal 106 KiloPascal Handling Environment Humidity 30 Percent (%) Relative Humidity 75 Percent (%) Relative Humidity Handling Environment Temperature -10 Degrees Celsius 40 Degrees Celsius Special Storage Condition, Specify 0 0 Keep Dry, Protect from freezing, Avoid excessive heat Storage Environment Atmospheric Pressure 70 KiloPascal 106 KiloPascal Storage Environment Humidity 10 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity Storage Environment Temperature -10 Degrees Celsius 55 Degrees Celsius
Regulatory Flags# DUNS number 025460908 Device count 1 Premarket exempt true Lot or batch true Serial number true Manufacturing date on label true No natural rubber latex true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 06980134820016 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820023 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820030 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820047 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820054 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820061 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820078 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820085 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820092 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820108 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820115 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820122 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820139 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820146 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820153 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820160 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820177 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820184 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820191 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820207 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820214 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820221 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820238 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820245 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820252 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820269 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820276 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820283 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06973967150658 Eara Xiamen Vienatone Medical Technology Co., Ltd. QUG 2026-05-19 06971094538677 AntOkay Huizhou Jinghao Medical Technology Co., Ltd QUG 2026-05-01
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