Patient Response Button

GUDID 04260223140884

Patient response button. PATH MEDICAL is not manufacturer or Labeler of this product. This Product was uploaded to GUDID erroneously by PATH MEDICAL.

PATH medical GmbH

Evoked-potential audiometer

• Primary Device ID: 04260223140884
• NIH Device Record Key: 51e3193b-9791-4073-91d4-cc803ebfb2eb
• Commercial Distribution Discontinuation: 2017-02-24
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Patient Response Button
• Version Model Number: 100171
• 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	04260223140884 [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