Madsen A450 8-04-14662

GUDID 05713315010293

1081 Madsen A450

Gn Otometrics A/S

Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer

• Primary Device ID: 05713315010293
• NIH Device Record Key: 0ecb8ee5-845e-48c8-8a1c-52905a00816c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Madsen A450
• Version Model Number: 8-04-14662
• Catalog Number: 8-04-14662
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05713315010293 [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: 2023-08-03
• Device Publish Date: 2022-12-28

On-Brand Devices [Madsen A450]

• 05713315010293: 1081 Madsen A450
• 05713315010286: 1081 Madsen A450
• 05713315010279: 1081 Madsen A450