Primus By Auditdata

GUDID 05711781000022

Auditdata A/S

Hearing aid tester, electrical

• Primary Device ID: 05711781000022
• NIH Device Record Key: d0223c32-d619-4e8b-bfbc-91aaa5636ee5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Primus By Auditdata
• Version Model Number: 2000 Primus HIT Unit
• 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: 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	05711781000022 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-03-05
• Device Publish Date: 2016-09-22

On-Brand Devices [Primus By Auditdata]

• 05711781001739: 2000 Primus HIT Pro
• 05711781001685: 2000 Primus Fitting Unit +
• 05711781001098: 2000 Primus Fitting Unit Ice
• 05711781001050: 2000 Primus Fitting Unit Pro
• 05711781000022: 2000 Primus HIT Unit
• 57117810001054: 2000 Primus Fitting Unit Pro