Unity 4 / Measure 100.053

GUDID 05711781002835

2000-1 Fitting Unit Audiometer

Auditdata A/S

Audiometric/hearing aid tester

• Primary Device ID: 05711781002835
• NIH Device Record Key: 1c9ae2c8-0e13-4786-b098-14763ad6fa94
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unity 4 / Measure
• Version Model Number: DD45 Headphone w. HBA (2000-1)
• Catalog Number: 100.053
• 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	05711781002835 [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 / Measure]

• 05711781003078: 2000-1 Fitting Unit Audiometer
• 05711781002866: 2000-1 Fitting Unit Audiometer
• 05711781002835: 2000-1 Fitting Unit Audiometer
• 05711781002828: 2000-1 Fitting Unit Audiometer
• 05711781002804: 2000-1 Fitting Unit Audiometer
• 05711781002774: 2000-1 Fitting Unit Audiometer
• 05711781002736: 2000-1 Fitting Unit Audiometer
• 05711781002729: 2000-1 Fitting Unit Audiometer
• 05711781003818: UNITY 4 PROBE MIC US PACKAGE