FDA.reportPublic FDA data

UNITRON

Primary DI
07630034382488
Brand
UNITRON
Company
Unitron Hearing Ltd
Model
050-6014-01
Catalog number
050-6014-01
Device description
T Moxi All Pro (beige)
Published
2018-06-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

Code, Name table
CodeName
KLWMasker, tinnitus
OSMHearing aid, air conduction with wireless technology

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630034382488PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630034382488076300343824887630034382488

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 519 895 0100Quality@unitron.com

Regulatory Flags#

DUNS number
201252087
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00698764593694Unitron076-5037-T820076-5037-T8202016-09-12
00698764424127Unitron076-5016-M520076-5016-M5202016-09-12
00698764424769Unitron076-5014-00001076-5014-000012016-09-12
00698764479707Unitron050-5600-P6050-5600-P62016-09-12
07630034300000Unitron050-5695-P7050-5695-P72016-09-12
07630034300017Unitron050-5695-P6050-5695-P62016-09-12
07630034300024Unitron050-5694-S7050-5694-S72016-09-12
07630034300031Unitron050-5694-S6050-5694-S62016-09-12
07630034300048Unitron050-5694-S5050-5694-S52016-09-12
07630034300055Unitron050-5694-S3050-5694-S32016-09-12
07630034300062Unitron050-5694-S2050-5694-S22016-09-12
07630034300079Unitron050-5694-Q9050-5694-Q92016-09-12
07630034300086Unitron050-5694-P8050-5694-P82016-09-12
07630034300093Unitron050-5694-P7050-5694-P72016-09-12
07630034300109Unitron050-5694-P6050-5694-P62016-09-12
07630034300116Unitron050-5694-P4050-5694-P42016-09-12
07630034300123Unitron050-5694-P2050-5694-P22016-09-12
07630034300130Unitron050-5694-01050-5694-012016-09-12
07630034300147Unitron050-5693-S7050-5693-S72016-09-12
07630034300154Unitron050-5693-S6050-5693-S62016-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05714880295719SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295719SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295726SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295726SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295733SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295733SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295740SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295740SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295788SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295788SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295795SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295795SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295849SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295849SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295856SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295856SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295900SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295900SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295917SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295917SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295986SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295986SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880296013SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880296013SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880296044SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880296044SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880296075SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880296075SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880296105SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880296105SIGNIAWs Audiology Usa, Inc.OSM2026-06-08