FDA.reportPublic FDA data

AccuScreen

Primary DI
05713315008948
Brand
AccuScreen
Company
Natus Medical Denmark ApS
Model
8-04-13963
Device description
1077 AccuScreen TE/DP
Published
2021-03-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GWJStimulator, Auditory, Evoked Response

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05713315008948PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713315008948057133150089485713315008948

GMDN Terms#

Term, Definition table
TermDefinition
Auditory stimulatorA mains electricity (AC-powered) device that applies sound stimuli (e.g., pure tones, speech) to a patient's acoustic system. It is typically used as a component of several types of devices such as audiometers, auditory evoked-potential recording systems, and auditory function screening devices.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
306633756
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
05713315011443ALGO Pro0362440362442026-01-23

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08056446901137NExT-HSEB NEURO SPAGWJ2025-05-22
08056446901168NExT-AMPEB NEURO SPAGWJ2025-05-22
08056446901199NExT-ASEB NEURO SPAGWJ2025-05-22
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08056446901090NExT Station AdvancedEB NEURO SPAGWJ2025-05-19
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00195278466662E-EEGXGE Healthcare Finland OyGWJ2022-07-01
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00382830045315Echo-Screen III ProNATUS MEDICAL INCORPORATEDGWJ2020-02-20
00382830045339Echo-Screen III ProNATUS MEDICAL INCORPORATEDGWJ2020-02-20
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08056446900215NeMus PC PERIPHERALEB NEURO SPAGWJ2019-05-24
08056446900222NeMus 1EB NEURO SPAGWJ2019-05-24
08056446900239NeMus 1EB NEURO SPAGWJ2019-05-24
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