FDA.report

GN ReSound

Primary DI
05708296052073
Brand
GN ReSound
Company
Gn Hearing A/S
Model
18787300
Device description
ASM,AIRLINK 2
Published
2019-01-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
OSMHearing aid, air conduction with wireless technology

Product Code Classifications

CodeDeviceSpecialtyClass
OSMHearing Aid, Air-Conduction With Wireless Technology, PrescriptionEar, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05708296052073PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05708296052073057082960520735708296052073

GMDN Terms

TermDefinition
Hearing aid wireless-fitting computer-aided setA collection of devices designed to work in conjunction with a computer to transmit wireless data to a hearing aid for computer-aided adjustment of the hearing aid while it is being fitted to a patient by healthcare personnel. It primarily consists of computer application software and a neck loop to establish the wireless link (the radio link protocol) with the hearing aid. The hearing aid must be compatible for wireless data reception and may be behind-the-ear (BTE), in-the-ear (ITE) and completely-in-the-canal (CIC) types.

Sterilization Methods

Method

Contacts

PhoneEmail
+1-888-735-4327consumerhelp@gnresound.com

Regulatory Flags

DUNS number
306179227
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 DIBrandModelCatalogPublished
05708296390243GN Hearing237709002026-03-05
05708296390328GN Hearing237717002026-03-05
05708296390410GN Hearing237726002026-03-05
05708296429073GN HearingJEC1CIC-HP2026-03-05
05708296429080GN HearingJEC1CIC-LP2026-03-05
05708296429097GN HearingJEC1CIC-MP2026-03-05
05708296429103GN HearingJEC1ITC-C-HP2026-03-05
05708296429110GN HearingJEC1ITC-C-LP2026-03-05
05708296429127GN HearingJEC1ITC-C-MP2026-03-05
05708296429134GN HearingJEC1ITC-C-UP2026-03-05
05708296429141GN HearingJEC1ITC-HP2026-03-05
05708296429158GN HearingJEC1ITC-LP2026-03-05
05708296429165GN HearingJEC1ITC-MP2026-03-05
05708296429172GN HearingJEC1ITC-UP2026-03-05
05708296429189GN HearingJEC1ITE-C-HP2026-03-05
05708296429196GN HearingJEC1ITE-C-MP2026-03-05
05708296429202GN HearingJEC1ITE-C-UP2026-03-05
05708296382927BeltoneILU17CIC-HP2026-02-10
05708296382934BeltoneILU17CIC-LP2026-02-10
05708296382941BeltoneILU17CIC-MP2026-02-10

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