FDA.reportPublic FDA data

QScreen Set

Primary DI
04260223146299
Brand
QScreen Set
Company
PATH medical GmbH
Model
101275-D-A-ECC
Device description
Set consisting of:P/N 101249 or 101249-17 Carrying Bag QScreenP/N 101199 QScreenP/N 101253 Docking Station QScreenP/N 101023 EP-LTP/N 100970 PECC-HPP/N 101205 Electrode cable with mini clips or 101256 Electrode cable with crocodile clipsP/N 100337-QScreen FW ABR QuickP/N 100424-QScreen FW Binaural ABRP/N 100110-QScreen FW DPOAEP/N 100536-QScreen FW FMDPOAEP/N 100414-QScreen FW LabelprinterP/N 101043 Accessory box EP-LT (AB-LT01)P/N 100890-5 Ear coupler, 5 pcs.P/N 100468 Electrodes, bag of 30 pcs.P/N 101250-12W-NEO Power SupplyP/N 101251-USA Power Supply Adapter P/N 101203-EN QScreen Manual english
Published
2023-05-19
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220139000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220139000QScreenPath Medical GmbH2022-08-03GWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260223146299PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260223146299042602231462994260223146299

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
551540334
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260223147753Ear Coupler TR 30 pairs101506-302026-07-29
04260223145995Ear Coupler Set100890-302026-07-24
04260223147579Infant Insert Eartips 4.0mm (bag of 20)100905-P-202026-07-24
04260223147586Infant Insert Eartips 3.5mm (bag of 20)100906-P-202026-07-24
04260223147654Bone Conductor BC-2LD1014752026-07-24
04260223147661Bone Conductor BC-2LD1014762026-07-24
04260223147678Bone Conductor BC-2LD1014772026-07-24
04260223147746Ear Coupler TR1015062026-07-24
04260223147975PIEP (2x2)1013442026-07-24
04260223148002Accessory box AB-LT021013402026-07-24
04260223147326nanoAudio DD45101414-012025-08-05
04260223147333nanoAudio DD65v2101414-022025-08-05
04260223147340nanoAudio Patient Response Button1014202025-08-05
04260223147418Sentiero Screening 3100098-S32025-08-05
04260223147449nanoAudio DD45 Set101470-012025-08-05
04260223147456nanoAudio DD45 Set with Patient Response Button101470-022025-08-05
04260223147463nanoAudio DD45 Set with Patient Response Button and Hughson-Westlake101470-032025-08-05
04260223147470nanoAudio DD65v2 Set101470-042025-08-05
04260223147487nanoAudio DD65v2 Set with Patient Response Button101470-052025-08-05
04260223147494nanoAudio DD65v2 Set with Patient Response Button and Hughson-Westlake101470-062025-08-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260223147753Ear Coupler TR 30 pairsPATH medical GmbHGWJ2026-07-29
05711117244540InteracousticsInteracoustics A/SGWJ2026-07-28
05711117244557InteracousticsInteracoustics A/SGWJ2026-07-28
04260223145995Ear Coupler SetPATH medical GmbHGWJ2026-07-24
04260223147579Infant Insert Eartips 4.0mm (bag of 20)PATH medical GmbHGWJ2026-07-24
04260223147586Infant Insert Eartips 3.5mm (bag of 20)PATH medical GmbHGWJ2026-07-24
04260223147654Bone Conductor BC-2LDPATH medical GmbHGWJ2026-07-24
04260223147661Bone Conductor BC-2LDPATH medical GmbHGWJ2026-07-24
04260223147678Bone Conductor BC-2LDPATH medical GmbHGWJ2026-07-24
04260223147746Ear Coupler TRPATH medical GmbHGWJ2026-07-24
04260223147975PIEP (2x2)PATH medical GmbHGWJ2026-07-24
04260223148002Accessory box AB-LT02PATH medical GmbHGWJ2026-07-24
05713315006890Madsen AccsucreenNatus Medical Denmark ApSGWJ2026-07-08
05713315006906Madsen AccuscreenNatus Medical Denmark ApSGWJ2026-07-08
00860016073401Evoke EEG SystemFirefly Neuroscience, Inc.GWJ2026-07-07
00860016073418Evoke EEG System AmplifierFirefly Neuroscience, Inc.GWJ2026-07-07
00817020020723Screener CartINTELLIGENT HEARING SYSTEMS CORP.GWJ2026-06-10
00817020020990Trigger Out Cable for USB Jr DuetINTELLIGENT HEARING SYSTEMS CORP.GWJ2026-06-10
00817020021140Diagnostic CartINTELLIGENT HEARING SYSTEMS CORP.GWJ2026-06-10
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