Vemp Monitor

GUDID 05713315008801

Vemp Monitor

Gn Otometrics A/S

Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator

• Primary Device ID: 05713315008801
• NIH Device Record Key: bf3a1fd8-536d-40b3-8e3b-cf238b7de9fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vemp Monitor
• Version Model Number: 8-36-00500
• Company DUNS: 306633756
• Company Name: Gn Otometrics A/S
• 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: 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	05713315008801 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083399

FDA Product Code

• GWJ: Stimulator, Auditory, Evoked Response

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: 2021-03-05
• Device Publish Date: 2021-02-25

On-Brand Devices [Vemp Monitor]

• 05713315008801: Vemp Monitor
• 05713315008795: Vemp Monitor, Chartr EP