ICS 8-40-00800

GUDID 05713315008757

Loop Back Tester for ICS Chartr EP 200

Gn Otometrics A/S

Auditory stimulator

• Primary Device ID: 05713315008757
• NIH Device Record Key: bac75dd7-05f2-4c5d-9e35-b8e1ad543be0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ICS
• Version Model Number: LOOP BACK TESTER, EP 200
• Catalog Number: 8-40-00800
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05713315008757 [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: 2021-08-20
• Device Publish Date: 2021-08-12

On-Brand Devices [ICS]

• 05713315009266: AirCal Caloric Stimulator, Extended (Extended length - 4m)
• 05713315009259: AirCal Caloric Stimulator, Extended (Extended length - 4m)
• 05713315009242: AirCal Caloric Stimulator, Extended (Extended length - 4m)
• 05713315009235: AirCal Caloric Stimulator (Standard length - 3m)
• 05713315008788: Preamp Lanyard for ICS Chartr EP 200
• 05713315008771: Preamp Shoulder Harness for ICS Chartr EP 200
• 05713315008764: Starter Kit for ICS Chartr EP 200
• 05713315008757: Loop Back Tester for ICS Chartr EP 200
• 05713315008740: Pre-Amp for ICS Chartr EP 200