FDA.report

Medline

Primary DI
20197344013255
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
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
QUGHearing Aid, Air-Conduction with Wireless Technology, Over the Counter

Product Code Classifications

CodeDeviceSpecialtyClass
QUGHearing Aid, Air-Conduction With Wireless Technology, Over The CounterEar, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20197344013255PackageGS130In Commercial Distribution
00197344013251PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2019734401325520197344013255
00197344013251001973440132511973440132510197344013251

GMDN Terms

TermDefinition
Air-conduction hearing aid, in-the-earA 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

TypeLowHighCondition
Handling Environment Atmospheric Pressure86 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature-10 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00Keep Dry, Protect from freezing, Avoid excessive heat
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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10884389110003MEDLINECRI5001BCRI5001B2026-03-24
10884389110010MEDLINECRI5000BCRI5000B2026-03-24
10884389110072MEDLINENONTH200BNONTH200B2026-03-24
30193489036224MEDLINEMDSE2RDCAMDSE2RDCA2022-12-10
30193489036248MEDLINEMDSE2RDCPMDSE2RDCP2022-12-10
30193489036262MEDLINEMDSE2X2CAMDSE2X2CA2022-12-10
40888277170897MEDLINEFG1501FG15012026-03-20
40888277170972MEDLINEFG1503FG15032026-03-20
40888277358455MEDLINEMPHPN315MPHPN3152026-03-19
40888277358462MEDLINEMPHPN318MPHPN3182026-03-19
20197344009807HUDSON RCIHUD2417HUD24172026-03-19
20080196286789MEDLINEMDT2168282MDT21682822016-10-14
20080196765574MEDLINE INDUSTRIES, INC.NONLV200NONLV2002025-05-28
10197344010264HUDSON RCIHUD1846HUD18462026-03-19
20884389108199MEDLINE INDUSTRIES, INC.NONLV200XXXLNONLV200XXXL2024-03-05
20884389108229MEDLINENONLV200XXLNONLV200XXL2025-05-27
20884389155360MEDLINENONLV240NONLV2402025-05-27
20884389155377MEDLINENONLV240XLNONLV240XL2025-05-27
20888277336893MEDLINENON50240NON502402025-05-27

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00850080488249flysoundShenzhen Flysounds Medical Technology Co.,Ltd.QUG2026-03-06
16974308960209Retone, NebrooXiamen Retone Hearing Technology Co., LtdQUG2026-02-05
00850080488140flysoundShenzhen Flysounds Medical Technology Co.,Ltd.QUG2026-01-16
05714880290356hear.comWs Audiology Usa, Inc.QUG2026-01-12
16974308960193Retone Xiamen Retone Hearing Technology Co., LtdQUG2026-01-08
06977352080438ELEHEARELEHEAR Inc.QUG2025-12-31
06943786079911AUSTARAustar Hearing Science & Technology (Xiamen) Co., Ltd men) Co., Ltd.QUG2025-12-03
05708296386239GN HearingGn Hearing A/SQUG2025-09-21
05708296386246GN HearingGn Hearing A/SQUG2025-09-21
05708296391240GN HearingGn Hearing A/SQUG2025-09-21
05708296386253GN HearingGn Hearing A/SQUG2025-09-19
05708296386260GN HearingGn Hearing A/SQUG2025-09-19
05708296386277GN HearingGn Hearing A/SQUG2025-09-19
05708296386284GN HearingGn Hearing A/SQUG2025-09-19
05708296386291GN HearingGn Hearing A/SQUG2025-09-19
05708296386307GN HearingGn Hearing A/SQUG2025-09-19
05708296386314GN HearingGn Hearing A/SQUG2025-09-19
05708296386321GN HearingGn Hearing A/SQUG2025-09-19
05708296386338GN HearingGn Hearing A/SQUG2025-09-19
05708296386345GN HearingGn Hearing A/SQUG2025-09-19
05708296386352GN HearingGn Hearing A/SQUG2025-09-19
05708296386369GN HearingGn Hearing A/SQUG2025-09-19
05708296386376GN HearingGn Hearing A/SQUG2025-09-19
05708296391189GN HearingGn Hearing A/SQUG2025-09-19
05708296391196GN HearingGn Hearing A/SQUG2025-09-19
05708296391202GN HearingGn Hearing A/SQUG2025-09-19
05708296391219GN HearingGn Hearing A/SQUG2025-09-19
05708296391226GN HearingGn Hearing A/SQUG2025-09-19
05708296391233GN HearingGn Hearing A/SQUG2025-09-19
05708296391257GN HearingGn Hearing A/SQUG2025-09-19