Madsen Astera 2 8-04-13402

GUDID 05713315010187

1066 MADSEN Astera 2

Natus Medical Denmark ApS

Tone audiometer, manual

• Primary Device ID: 05713315010187
• NIH Device Record Key: c3e4329e-63c3-4181-93f4-4ff277fcd547
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Madsen Astera 2
• Version Model Number: 8-04-13402
• Catalog Number: 8-04-13402
• Company DUNS: 306633756
• Company Name: Natus Medical Denmark ApS
• 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: true
• 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	05713315010187 [Primary]

FDA Product Code

• EWO: Audiometer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-04-18
• Device Publish Date: 2022-12-28

On-Brand Devices [Madsen Astera 2]

• 05713315010194: 1066 MADSEN Astera 2
• 05713315010187: 1066 MADSEN Astera 2