Sentiero Desktop AuDX PRO FLEX 100497-BL-US1

GUDID 04260223143540

Sentiero Desktop AuDX PRO FLEX Set: Content: 1. Sentiero Desktop AN100434-AUPF 2. Cardboard Box AN100728 3. Cardboard Sleeve Bio-Logic AN100723-Biolog

PATH medical GmbH

Evoked-potential audiometer

• Primary Device ID: 04260223143540
• NIH Device Record Key: 24f73d05-0923-47d0-a743-0ee36ffcddaa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sentiero Desktop AuDX PRO FLEX
• Version Model Number: 8-04-16540
• Catalog Number: 100497-BL-US1
• 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	04260223143540 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133012

FDA Product Code

• ETY: Tester, Auditory Impedance

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-06-01

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)