Vemp Monitor

GUDID 05713315008795

Vemp Monitor, Chartr EP

Gn Otometrics A/S

Auditory stimulator

• Primary Device ID: 05713315008795
• NIH Device Record Key: 5c04946f-0629-478e-affe-e0f446b61fe7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vemp Monitor
• Version Model Number: 8-36-00520
• 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: true
• 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	05713315008795 [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: 2021-03-12
• Device Publish Date: 2021-03-04

On-Brand Devices [Vemp Monitor]

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