Madsen

GUDID 05713315009204

Madsen Astera2 clinical audiometer

Gn Otometrics A/S

Tone audiometer, semi-automated

• Primary Device ID: 05713315009204
• NIH Device Record Key: d7188312-34e2-44d9-b705-bbb58392307d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Madsen
• Version Model Number: 8-04-13102-CA
• 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	05713315009204 [Primary]

FDA Product Code

• EWO: Audiometer

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: 2021-07-09
• Device Publish Date: 2021-07-01

On-Brand Devices [Madsen]

• 05713315009228: Madsen A450 audiometer
• 05713315009204: Madsen Astera2 clinical audiometer
• 05713315009013: Cavity set of sizes 0.1, 0.5, 2 and 4 cc for Madsen Otoflex 100