FDA.reportPublic FDA data

Natus

Primary DI
05713315008641
Brand
Natus
Company
Natus Medical Denmark ApS
Model
8-66-22410
Catalog number
8-66-22410
Device description
AccuScreen Ear Couplers (25 sets of 2)
Published
2020-12-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
GWJStimulator, Auditory, Evoked Response

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWJStimulator, Auditory, Evoked ResponseNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132957000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132957000MADSEN ACCUSCREEN TYPE 1077Gn Otometrics2014-02-27GWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05713315008641PrimaryGS10
05713315008634Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713315008641057133150086415713315008641
05713315008634057133150086345713315008634

GMDN Terms#

Term, Definition table
TermDefinition
Evoked-potential audiometerAn electroacoustic instrument designed to evaluate the activity of the auditory pathway of the brain in response to an acoustic signal [auditory brainstem response (ABR)] it provides at the ear (e.g., clicks delivered through an earphone), without need of patient cooperation. The signal, detected via the device's scalp electrodes and possibly a reference electrode on the ear lobe, is measured using computer averaging and signal processing techniques. This device is typically used to assess the function of the auditory pathways and to differentiate coma due to metabolic factors from structural damage.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
306633756
Device count
25
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
05713315011641RetCam EnvisionRETCAM-FA-UPGRADERETCAM-FA-UPGRADE2026-02-10
05713315011924RetCam Envision60-00007060-0000702026-02-10
05713315011931RetCam Envision60-00009060-0000902026-02-10
05713315011948RetCam Envision60-00009260-0000922026-02-10
05713315011962RetCam Envision61-00050061-0005002026-02-10
05713315012068Echo-Screen III0135700135702026-01-29
05713315012013Echo-Screen III0091490091492026-01-28
05713315012037Echo-Screen III0109990109992026-01-28
05713315012051Echo-Screen III0126250126252026-01-28
05713315011436ALGO Pro0361770361772026-01-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B592SW100WAVi Scan SoftwareWAVI CO.GWJ2026-03-25
B592WD100WAVi Electrical Processing UnitWAVI CO.GWJ2026-03-25
B592WK200WAVi Scan KitWAVI CO.GWJ2026-03-25
08056446901106NExT-DOCKINGEB NEURO SPAGWJ2025-05-22
08056446901113NExT-PADEB NEURO SPAGWJ2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAGWJ2025-05-22
08056446901137NExT-HSEB NEURO SPAGWJ2025-05-22
08056446901168NExT-AMPEB NEURO SPAGWJ2025-05-22
08056446901199NExT-ASEB NEURO SPAGWJ2025-05-22
08056446901205NExT StationEB NEURO SPAGWJ2025-05-22
08056446901090NExT Station AdvancedEB NEURO SPAGWJ2025-05-19
00817020021126AriaINTELLIGENT HEARING SYSTEMS CORP.GWJ2024-03-11
00627908020178EP HeadphonesVivosonic IncGWJ2023-06-08
00627908020185ECochG AdaptersVivosonic IncGWJ2023-06-08
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyGWJ2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyGWJ2023-04-19
00195278524089NAGE Healthcare Finland OyGWJ2023-04-19
00195278466662E-EEGXGE Healthcare Finland OyGWJ2022-07-01
00195278466679N-EEGXGE Healthcare Finland OyGWJ2022-07-01
08056446900642Galileo NT Line SoftwareEB NEURO SPAGWJ2020-05-25
00382830045247Echo-Screen III ProNATUS MEDICAL INCORPORATEDGWJ2020-02-20
00382830045278Echo-Screen III ProNATUS MEDICAL INCORPORATEDGWJ2020-02-20
00382830045292Echo-Screen III ProNATUS MEDICAL INCORPORATEDGWJ2020-02-20
00382830045315Echo-Screen III ProNATUS MEDICAL INCORPORATEDGWJ2020-02-20
00382830045339Echo-Screen III ProNATUS MEDICAL INCORPORATEDGWJ2020-02-20
00382830045353Echo-Screen III ProNATUS MEDICAL INCORPORATEDGWJ2020-02-20
08056446900208NeMus SYSTEMEB NEURO SPAGWJ2019-05-24
08056446900215NeMus PC PERIPHERALEB NEURO SPAGWJ2019-05-24
08056446900222NeMus 1EB NEURO SPAGWJ2019-05-24
08056446900239NeMus 1EB NEURO SPAGWJ2019-05-24