Measure 100.115

GUDID 05711781002743

2000-1 Fitting Unit Audiometer SW

Auditdata A/S

Audiometric/hearing aid tester

• Primary Device ID: 05711781002743
• NIH Device Record Key: 5bfabddb-29e6-4999-84de-6f05846a8734
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Measure
• Version Model Number: Measure Software (USB stick)
• Catalog Number: 100.115
• 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	05711781002743 [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: 2024-09-25
• Device Publish Date: 2024-09-17

Devices Manufactured by Auditdata A/S

• 05711781004006 - Unity 3: 2024-10-29 U3HIT Package AD-version US
• 05711781002743 - Measure: 2024-09-252000-1 Fitting Unit Audiometer SW
• 05711781002743 - Measure: 2024-09-25 2000-1 Fitting Unit Audiometer SW
• 05711781003818 - Unity 4 / Measure: 2024-09-25
• 00571178100316 - Unity 4: 2024-08-29 2000-1 Fitting Unit Audiometer
• 05711781002729 - Unity 4 / Measure: 2024-08-29 2000-1 Fitting Unit Audiometer
• 05711781002736 - Unity 4 / Measure: 2024-08-29 2000-1 Fitting Unit Audiometer
• 05711781002750 - Unity 4: 2024-08-29 2000-1 Fitting Unit Audiometer
• 05711781002774 - Unity 4 / Measure: 2024-08-29 2000-1 Fitting Unit Audiometer