Sentiero Desktop AuDX PRO Flex Set

GUDID 04260223143359

content: - carrying bag A/N100503 - USB Cable A/N100418 - AuDX PRO Flex A/N100434-AUPF - Probe EP-TY A/N100188-US - Insert Earphone Bio- Logic A/N100860-BL - Bone Conductor B71 A/N100344 - Gooseneck Microphone A/N100779 - FW Reflex & Tymp Class1 A/N100561 - FW TEOAE A/N100109 - FW DPOAE A/N100110 - FW FMDPOAE A/N100536 - FW DPHiRES A/N100537 - FW Mira PC- Software A/N100116 - FW PTA3 A/N100114 - FW High Frequency A/N100454 - FW Magic A/N100112 - FW Labelprinter A/N100414 - Accessory Box Combo A/N100261 - Power Supply Senti/Sentiero Desktop US A/N100524 - User Manual A/N100904-EN-BL - Test Cavity Tymp A/N100549

PATH medical GmbH

Evoked-potential audiometer

• Primary Device ID: 04260223143359
• NIH Device Record Key: 258e865e-32fc-49cc-b632-4cd1103543bb
• Commercial Distribution Discontinuation: 2020-06-29
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Sentiero Desktop AuDX PRO Flex Set
• Version Model Number: 100497-BLP1
• Company DUNS: 551540334
• Company Name: PATH medical GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260223143359 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133012

FDA Product Code

• GWJ: Stimulator, Auditory, Evoked Response

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-06-30
• Device Publish Date: 2018-04-10

Devices Manufactured by PATH medical GmbH

• 04260223147326 - nanoAudio DD45: 2025-08-13 nanoAudio audiometer device with headphone DD45
• 04260223147333 - nanoAudio DD65v2: 2025-08-13 nanoAudio audiometer device with headphone DD65v2
• 04260223147340 - nanoAudio Patient Response Button: 2025-08-13 Patient response button for nanoAudio
• 04260223147418 - Sentiero Screening 3: 2025-08-13 Sentiero Screening3 Device with Touchscreen
• 04260223147449 - nanoAudio DD45 Set: 2025-08-13 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 Button: 2025-08-13 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-Westlake: 2025-08-13 Bill of materials for convenience kit: 1. nanoAudio DD45 device (101414-01) 2. English manual (101450-EN) 3. Lanyard (101458) 4.
• 04260223147470 - nanoAudio DD65v2 Set: 2025-08-13 Bill of materials for convenience kit: 1. nanoAudio DD65v2 device (101414-02) 2. English manual (101450-EN) 3. Lanyard (101458)