MADSEN Astera 2 8-04-13124

GUDID 05713315007521

1066 MADSEN Astera 2 with ACP, ISO Calibration Incl. ME70 Headset and BC-1 Bone conductor

Gn Otometrics A/S

Speech audiometer

• Primary Device ID: 05713315007521
• NIH Device Record Key: 7ed2a38c-0425-47bf-902c-9f97472359b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MADSEN Astera 2
• Version Model Number: 8-04-13124
• Catalog Number: 8-04-13124
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05713315007521 [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: 2024-12-20
• Device Publish Date: 2024-12-12

On-Brand Devices [MADSEN Astera 2]

• 05713315007859: 1066 MADSEN Astera 2 with ACPDS, Including HB-7 Headset, Insert Phone and DD450
• 05713315007521: 1066 MADSEN Astera 2 with ACP, ISO Calibration Incl. ME70 Headset and BC-1 Bone conductor
• 05713315007477: 1066 MADSEN Astera 2 without ACP ANSI Cal.Incl. ME70 Headset, Insert Earphone, BC-1 BC
• 05713315007439: 1066 MADSEN Astera 2 w/ACP, ISO Cal. HB-7, Insert phone, DD450, B71 BC, Wall Mount Kit
• 05713315007415: 1066 MADSEN Astera 2 with ACP, ISO Cal. Incl. HB-7 Headset, B71 BC and Wall Mounting Kit