FDA.reportPublic FDA data

Madsen Zodiac

Primary DI
05713315009501
Brand
Madsen Zodiac
Company
Natus Medical Denmark ApS
Model
8-04-16311
Catalog number
8-04-16311
Device description
1096 Zodiac SA Diag. with printer
Published
2026-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
ETYTester, Auditory Impedance

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETYTester, Auditory ImpedanceEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05713315009501PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713315009501057133150095015713315009501

GMDN Terms#

Term, Definition table
TermDefinition
Impedance audiometerAn electronic instrument used to evaluate the functional condition of the middle ear by changing the air pressure in the external auditory canal to measure and graph the mobility characteristics of the tympanic membrane. It identifies abnormalities in tympanic membrane mobility due to stiffness, flaccidity, or the presence of fluid in the middle ear cavity. The device is also used to measure the acoustic reflex threshold from contractions of the stapedial muscle, to monitor healing of tympanic membrane grafts or stapedectomies, or to monitor follow up treatment for inflammation of the middle ear.

Regulatory Flags#

DUNS number
306633756
Device count
1
DM exempt
false
Premarket exempt
false
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05713315009426Madsen Zodiac8-04-163038-04-163032026-06-03
05713315009433Madsen Zodiac8-04-163048-04-163042026-06-03
05713315009457Madsen Zodiac8-04-163068-04-163062026-06-03
05713315009471Madsen Zodiac8-04-163088-04-163082026-06-03
05713315009488Madsen Zodiac8-04-163098-04-163092026-06-03
05713315009518Madsen Zodiac8-04-163128-04-163122026-06-03
05713315009525Madsen Zodiac8-04-163138-04-163132026-06-03
05713315009532Madsen Zodiac8-04-163148-04-163142026-06-03
05713315009556Madsen Zodiac8-04-163168-04-163162026-06-03
05713315009570Madsen Zodiac8-04-163188-04-163182026-06-03
05713315009402Madsen Zodiac8-04-163012026-06-02
05713315008474Otometrics1085, FACE CUSHION 2 ASM KIT8-35-501002020-06-02
05713315008443Otometrics1085, STRAP ASSEMBLY8-35-342002019-11-20
05713315008467Otometrics1085, FACE PAD ASSEMBLY KIT V28-35-393002020-05-18
05713315003295OtometricsGoggle face cushion kit2019-04-24
05713315005268GN Otometrics A/S1085, GOGGLE HOME KIT2016-09-23
05713315002915GN Otometrics A/SDisposable Diff VEMP Electrode2019-04-01
05713315002649GN Otometrics A/S"Disposable Electrode 24"" Wired Qty 10"2016-09-26
05713315000874GN Otometrics A/SOTOair Bluetooth Dongle2016-09-19
05713315011597RetCam Envision61-00030061-0003002026-02-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05713315009426Madsen ZodiacNatus Medical Denmark ApSETY2026-06-03
05713315009433Madsen ZodiacNatus Medical Denmark ApSETY2026-06-03
05713315009457Madsen ZodiacNatus Medical Denmark ApSETY2026-06-03
05713315009471Madsen ZodiacNatus Medical Denmark ApSETY2026-06-03
05713315009488Madsen ZodiacNatus Medical Denmark ApSETY2026-06-03
05713315009518Madsen ZodiacNatus Medical Denmark ApSETY2026-06-03
05713315009525Madsen ZodiacNatus Medical Denmark ApSETY2026-06-03
05713315009532Madsen ZodiacNatus Medical Denmark ApSETY2026-06-03
05713315009556Madsen ZodiacNatus Medical Denmark ApSETY2026-06-03
05713315009570Madsen ZodiacNatus Medical Denmark ApSETY2026-06-03
05713315009402Madsen ZodiacNatus Medical Denmark ApSETY2026-06-02
08051597160051ResonanceM.R.S. SRLETY2025-09-01
08051597160099ResonanceM.R.S. SRLETY2025-09-01
04260223142994Sentiero Desktop DiagnosticPATH medical GmbHETY2024-05-22
05060488902673Amplivox AMPLIVOX LIMITEDETY2024-01-08
05060488902635Amplivox AMPLIVOX LIMITEDETY2023-12-22
05060488902680Amplivox AMPLIVOX LIMITEDETY2023-12-22
00732094082760Welch Allyn, Inc.WELCH ALLYN, INC.ETY2023-08-17
00732094084580Welch Allyn, Inc.WELCH ALLYN, INC.ETY2023-08-17
00732094084597Welch Allyn, Inc.WELCH ALLYN, INC.ETY2023-08-17
00732094084702Welch Allyn, Inc.WELCH ALLYN, INC.ETY2023-08-17
00732094084719Welch Allyn, Inc.WELCH ALLYN, INC.ETY2023-08-17
00732094084726Welch Allyn, Inc.WELCH ALLYN, INC.ETY2023-08-17
00732094084733Welch Allyn, Inc.WELCH ALLYN, INC.ETY2023-08-17
05713315009396Madsen ZodiacNatus Medical Denmark ApSETY2022-12-15
05713315009907Madsen ZodiacNatus Medical Denmark ApSETY2022-12-15
05713315009914Madsen ZodiacNatus Medical Denmark ApSETY2022-12-15
05713315009389Madsen ZodiacNatus Medical Denmark ApSETY2022-12-12
05713315009464Madsen ZodiacNatus Medical Denmark ApSETY2022-12-05
00571331500946Madsen ZodiacGn Otometrics A/SETY2022-12-05