Intricon

Primary DI
00858177007588
Brand
Intricon
Company
INTRICON CORPORATION
Model
Lumen 155i1
Catalog number
93336-004
Device description
BTE Wireless Directional Hearing Aid, Light Gray
Published
2020-09-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
OSMHearing Aid, Air Conduction With Wireless Technology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OSMHearing Aid, Air-Conduction With Wireless Technology, PrescriptionEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858177007588PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858177007588008581770075888581770075880858177007588

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, behind-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 microphone, an amplifier, and a speaker (receiver) contained in a case worn behind-the-ear (BTE). 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 through an earmould that fits inside the outer ear or a tube in the ear canal. The device is used for mild to profound hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.

Contacts#

Phone, Email table
PhoneEmail
+1-651-636-9770udi@intricon.com

Regulatory Flags#

DUNS number
002345767
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858177007939AudicusONE933369-0162022-12-19
00858177007946AudicusONE93336-0172022-12-19
00858177007953AudicusONE93336-0182022-12-19
00858177007960IntriconLumen 155H93545-0002022-12-19
00858177007977IntriconLumen 155H93546-0002022-12-19
00858177007892AudicusONE93336-0132022-11-10
00858177007908AudicusONE93336-0142022-11-10
00858177007915AudicusONE93336-0152022-11-10
00858177007847BeurerL15593532-0052022-06-30
00858177007854BeurerL15593532-0062022-06-30
00858177007861BeurerL1552022-06-30
00858177007878BeurerL1552022-06-30
00858177007885BeurerL15593532-0092022-06-30
00858177007823PersonaL150i193057-0222022-06-21
00858177007830PersonaL150i193119-0282022-06-21
00858177007779BeurerL15593532-0002022-06-08
00858177007786BeurerL15593532-0012022-06-08
00858177007793BeurerL15593532-0022022-06-08
00858177007809BeurerL15593532-0032022-06-08
00858177007816BeurerL15593532-0042022-06-08

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