Sentiero Diagnostic

GUDID 04260223141454

Sentiero Diagnostic OAE Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. USB data cable AN100089 4. Sentiero Diagnostic device with touchscreen AN100098 5. Probe EP-DP Path long AN100028-US 6. Probe EP-VIP AN100539-US 7. TEOAE Software AN100109 8. DPOAE Software AN100110 9. DPHiRES Software AN100537 10. FMDPOAE Software AN100536 11. DPOAE Threshold Estimation Software AN100111 12. PC based Patient Management, Mira Software: Patient data & result transfer from instrument to PC, reporting options, export functions, printing via PC, data archive for Windows 10, Windows 7 etc. AN100116 13. Software label printer AN100414 14. Accessory box Sentiero Combo AN100261 15. Power supply Sentiero US AN101013+AN100993-USA

PATH medical GmbH

Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer

• Primary Device ID: 04260223141454
• NIH Device Record Key: a4262a59-8ec0-4088-bdde-f7a4344ccfcf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sentiero Diagnostic
• Version Model Number: 100250-US4
• 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	04260223141454 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133012

FDA Product Code

• EWO: Audiometer

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-06
• Device Publish Date: 2020-06-27

On-Brand Devices [Sentiero Diagnostic]

• 04260223141447: Sentiero Diagnostic OAE Audiometrie Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3.
• 04260223141430: Sentiero Diagnostic OAE Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. USB data cab
• 04260223145360: Sentiero Diagnostic TEOAE Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. USB data c
• 04260223141454: Sentiero Diagnostic OAE Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. USB data cab