Measure by Otometrics - HIT 100.451

GUDID 05711781004372

2000 Primus HIT Pro

Auditdata A/S

Hearing aid tester, electrical

• Primary Device ID: 05711781004372
• NIH Device Record Key: 7d93d308-bc4e-4a79-81e8-ea1e52c1d350
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Measure by Otometrics - HIT
• Version Model Number: US/CA AUD HIT Pro Package
• Catalog Number: 100.451
• 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: true
• Serial Number: true
• Manufacturing Date: true
• 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	05711781004372 [Primary]

FDA Product Code

• ETW: Calibrator, Hearing Aid / Earphone And Analysis Systems

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: 2025-11-24
• Device Publish Date: 2025-11-14

On-Brand Devices [Measure by Otometrics - HIT]

• 05711781004372: 2000 Primus HIT Pro
• 05711781004297: 2000 Primus HIT Pro