FDA.reportPublic FDA data

Lehiso

Primary DI
05713708000036
Brand
Lehiso
Company
Lehiso A/S
Model
178494
Device description
REMOTELINK 1.4 IOS
Published
2017-12-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
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
05713708000036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713708000036057137080000365713708000036

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
+4539177100hama@oticon.com

Regulatory Flags#

DUNS number
312009710
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
05713708000177Lehiso2044562019-08-22
05713708000184Lehiso2044572019-08-22
05713708000214Lehiso2147122020-05-11
05713708000221Lehiso2147142020-05-11
05713708000054Lehiso1857842017-11-30
05713708000078Lehiso1857892017-11-30
05713708000115Lehiso1892602018-08-20
05713708000122Lehiso1892612018-08-20
05713708000146Lehiso1995262019-02-20
05713708000153Lehiso1995272019-02-20
05713708000012Lehiso1784992017-12-11

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Primary DI, Brand, Company table
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00840388220788Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220795Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220801Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220818Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220825Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
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00840388220917Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220955Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
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00840388221006Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221013Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221020Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
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00840388221044Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221051Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221068Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221075Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221136Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221181Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221228Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221266Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221280Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221297Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221303Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221327Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04