FDA.reportPublic FDA data

Lehiso

Primary DI
05713708000177
Brand
Lehiso
Company
Lehiso A/S
Model
204456
Device description
REMOTELINK 2.0 IOS
Published
2019-08-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true

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
05713708000177PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713708000177057137080001775713708000177

GMDN Terms#

Term, Definition table
TermDefinition
Hearing aid/implant system remote controlA battery-powered device designed to be operated by the wearer of a hearing aid or a hearing implant system to enable discreet wireless (remote) adjustments to the device (e.g., volume and program changes). It is designed to be conveniently portable (e.g., carried in a pocket, handbag, or attached to a key ring).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4539177100eand@demant.com

Regulatory Flags#

DUNS number
312009710
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
05713708000036Lehiso1784942017-12-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840388220580Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220580Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220597Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220597Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220757Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220757Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220764Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220764Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220771Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220771Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220788Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220788Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220795Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220795Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220801Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220801Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220818Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220818Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220825Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220825Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220863Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220863Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220917Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220917Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220955Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220955Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220993Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220993Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221006Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221006Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04