Unity 4 100.116

GUDID 05711781002750

2000-1 Fitting Unit Audiometer

Auditdata A/S

Audiometric/hearing aid tester

• Primary Device ID: 05711781002750
• NIH Device Record Key: ac46772a-ed1b-414a-aec4-12d90cf4f650
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unity 4
• Version Model Number: Unity 4 USB Stick
• Catalog Number: 100.116
• Company DUNS: 310385849
• Company Name: Auditdata 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05711781002750 [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: 2024-08-29
• Device Publish Date: 2024-08-21

On-Brand Devices [Unity 4 ]

• 05711781002750: 2000-1 Fitting Unit Audiometer
• 00571178100316: 2000-1 Fitting Unit Audiometer