Patient Response Button

GUDID 04260223140860

Patient response button for Sentiero

PATH medical GmbH

Evoked-potential audiometer

• Primary Device ID: 04260223140860
• NIH Device Record Key: 073c0364-d6c9-450f-b4eb-0b3d091e2819
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Patient Response Button
• Version Model Number: 100169
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• 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	04260223140860 [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: 2018-07-06
• Device Publish Date: 2016-08-31

On-Brand Devices [Patient Response Button]

• 04260223140884: Patient response button. PATH MEDICAL is not manufacturer or Labeler of this product. This Produ
• 04260223140877: Patient response button for Sentiero Advanced
• 04260223140860: Patient response button for Sentiero