FDA.reportPublic FDA data

AUDIGY

Primary DI
00842318116987
Brand
AUDIGY
Company
Starkey Laboratories, Inc.
Model
AGXSM 1600 RIC 312t
Catalog number
64264-A
Published
2017-01-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
ESDHearing aid, air conduction
KLWMasker, tinnitus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ESDHearing Aid, Air-Conduction, PrescriptionEar, Nose, Throat1
KLWMasker, TinnitusEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842318116987PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842318116987008423181169878423181169870842318116987

GMDN Terms#

Term, Definition table
TermDefinition
Receiver-in-canal air-conduction hearing aidA battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It consists of a microphone and an amplifier in a case behind-the-ear (BTE) connected, via a wire, to a receiver (speaker) in the ear canal [receiver-in-canal (RIC)]. 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 profound 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
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
055461479
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840388220580Starkey G Series AI63406-1312026-09-04
00840388220597Starkey G Series AI63406-1402026-09-04
00840388220757Starkey G Series AI63406-1412026-09-04
00840388220764Starkey G Series AI63407-1312026-09-04
00840388220771Starkey G Series AI63407-1402026-09-04
00840388220788Starkey G Series AI63407-1412026-09-04
00840388220795Starkey G Series AI63408-1312026-09-04
00840388220801Starkey G Series AI63408-1402026-09-04
00840388220818Starkey G Series AI63408-1412026-09-04
00840388220825Starkey G Series AI63400-1312026-09-04
00840388220863Starkey G Series AI63400-1402026-09-04
00840388220917Starkey G Series AI63400-1412026-09-04
00840388220955Starkey G Series AI63401-1312026-09-04
00840388220993Starkey G Series AI63401-1402026-09-04
00840388221006Starkey G Series AI63401-1412026-09-04
00840388221013Starkey G Series AI63402-1312026-09-04
00840388221020Starkey G Series AI63402-1402026-09-04
00840388221037Starkey G Series AI63402-1412026-09-04
00840388221044Starkey G Series AI63430-1312026-09-04
00840388221051Starkey G Series AI63430-1402026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05714880250695Audio ServiceWs Audiology Usa, Inc.KLW2026-09-18
05714880250701Audio ServiceWs Audiology Usa, Inc.KLW2026-09-18
05714880250718Audio ServiceWs Audiology Usa, Inc.KLW2026-09-18
05714880250725Audio ServiceWs Audiology Usa, Inc.KLW2026-09-18
05714880250732Audio ServiceWs Audiology Usa, Inc.KLW2026-09-18
00840388220580Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220597Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220757Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220764Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220771Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220788Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220795Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220801Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220818Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220825Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220863Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220917Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220955Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220993Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221006Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221013Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221020Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221037Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221044Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221051Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221068Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221075Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221136Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221181Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221228Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04