Auditdata A/S 21031174

GUDID 05711781003122

UNITY 4 AUD US PACKAGE

Ws Audiology Usa, Inc.

Audiometric/hearing aid tester

• Primary Device ID: 05711781003122
• NIH Device Record Key: 05668a1e-844d-482c-8876-be10c0e762e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Auditdata A/S
• Version Model Number: UNITY 4
• Catalog Number: 21031174
• Company DUNS: 157412271
• Company Name: Ws Audiology Usa, Inc.
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05711781003122 [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: 2024-08-26
• Device Publish Date: 2024-08-16

On-Brand Devices [Auditdata A/S]

• 05711781003160: UNITY 4 INSITU PACKAGE
• 05711781003153: UNITY 4 AUD + REM US PACKAGE
• 05711781003122: UNITY 4 AUD US PACKAGE