QScreen 101199

GUDID 04260223145766

OAE and AEP Hearing Screener

PATH medical GmbH

Evoked-potential audiometer
Primary Device ID04260223145766
NIH Device Record Key189f6b12-e0e1-422f-8b06-1ffa1c57fb69
Commercial Distribution StatusIn Commercial Distribution
Brand NameQScreen
Version Model NumberPM1610
Catalog Number101199
Company DUNS551540334
Company NamePATH medical GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104260223145766 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWJStimulator, Auditory, Evoked Response

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-22
Device Publish Date2022-08-12

Devices Manufactured by PATH medical GmbH

04260223147326 - nanoAudio DD452025-08-13 nanoAudio audiometer device with headphone DD45
04260223147333 - nanoAudio DD65v22025-08-13 nanoAudio audiometer device with headphone DD65v2
04260223147340 - nanoAudio Patient Response Button2025-08-13 Patient response button for nanoAudio
04260223147418 - Sentiero Screening 32025-08-13 Sentiero Screening3 Device with Touchscreen
04260223147449 - nanoAudio DD45 Set2025-08-13 Bill of materials for convenience kit: 1. nanoAudio DD45 device (101414-01) 2. English manual (101450-EN) 3. Lanyard (101458) 4.
04260223147456 - nanoAudio DD45 Set with Patient Response Button2025-08-13 Bill of materials for convenience kit: 1. nanoAudio DD45 device (101414-01) 2. English manual (101450-EN) 3. Lanyard (101458) 4.
04260223147463 - nanoAudio DD45 Set with Patient Response Button and Hughson-Westlake2025-08-13 Bill of materials for convenience kit: 1. nanoAudio DD45 device (101414-01) 2. English manual (101450-EN) 3. Lanyard (101458) 4.
04260223147470 - nanoAudio DD65v2 Set2025-08-13 Bill of materials for convenience kit: 1. nanoAudio DD65v2 device (101414-02) 2. English manual (101450-EN) 3. Lanyard (101458)

Trademark Results [QScreen]

Mark Image

Registration | Serial
Company
Trademark
Application Date
QSCREEN
QSCREEN
88019765 not registered Dead/Abandoned
International Health Options Inc.
2018-06-28
QSCREEN
QSCREEN
87006492 5312496 Live/Registered
Quest Diagnostics Investments LLC
2016-04-19
QSCREEN
QSCREEN
79254894 5847878 Live/Registered
Barnes Group Suisse Industries GmbH
2019-02-21

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