Otometrics

GUDID 05713315005954

With TDH-39

Gn Otometrics A/S

Tone audiometer, automated

• Primary Device ID: 05713315005954
• NIH Device Record Key: e5c3f01b-cad0-4728-b9b8-8c814a53ff68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Otometrics
• Version Model Number: Madsen A450
• Company DUNS: 306633756
• Company Name: Gn Otometrics 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	05713315005954 [Primary]

FDA Product Code

• EWO: Audiometer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-06-07

On-Brand Devices [Otometrics]

• 05713315005978: Combined TDH-39 and inserts
• 05713315005961: With inserts
• 05713315005954: With TDH-39
• 05713315005862: 1085, Face Cushion 2 Box Kit
• 05713315002304: Adult IPSI probeset, HL. Calibration: HL
• 05713315003295: Goggle face cushion kit
• 05713315008467: 1085, FACE PAD ASSEMBLY KIT V2
• 05713315008566: 1085, FACE CUSHION 2 ASM KIT
• 05713315008443: 1085, STRAP ASSEMBLY