ALGO 7i Set 1 A7i-101127

GUDID 04260223145421

ALGO 7i Base Kit containing: 1x 101049 ALGO 7i 1x 101121 ALGO7i Multidata Cable 1x 100524 Power Supply 1x 100525-EU Power Supply Adapter EU 1x 100525-US Power Supply Adapter US 1x 100525-UK Power Supply Adapter UK 1x 100525-AUS Power Supply Adapter AUS 1x 101092-E ALGO 7i Basinet Hook 1x 101100-E ALGO 7i Check Kit 1x 101124-EN ALGO 7i User Manual 1x 101118 USB Stick 1x 100418 USB Cable 1x 101201 ALGO 7i Backback Set

PATH medical GmbH

Evoked-potential audiometer
Primary Device ID04260223145421
NIH Device Record Key2a0ec8e3-5c05-4049-a677-420222592fa0
Commercial Distribution StatusIn Commercial Distribution
Brand NameALGO 7i Set 1
Version Model Number101127
Catalog NumberA7i-101127
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 Kittrue
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
GS104260223145421 [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 Date2021-11-08
Device Publish Date2021-10-29

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)

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