ICS

GUDID 05713315009266

AirCal Caloric Stimulator, Extended (Extended length - 4m)

Gn Otometrics A/S

Diagnostic caloric vestibular stimulation system

• Primary Device ID: 05713315009266
• NIH Device Record Key: 61b65f91-da30-4180-9a1a-f18eb04593a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ICS
• Version Model Number: 8-04-13330
• Company DUNS: 306633756
• Company Name: Gn Otometrics A/S
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	05713315009266 [Primary]

FDA Product Code

• KHH: Stimulator, Caloric-Air

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: 2021-07-14
• Device Publish Date: 2021-07-06

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