Amplivox

GUDID 05060488902635

AMPLIVOX LIMITED

Vestibulo-auditory analysis system

• Primary Device ID: 05060488902635
• NIH Device Record Key: 8c90132c-daa1-438b-bc32-82d86acb7ada
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amplivox
• Version Model Number: Otowave 102-C
• Company DUNS: 226599157
• Company Name: AMPLIVOX LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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	05060488902635 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171265

FDA Product Code

• ETY: Tester, Auditory Impedance

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: 2024-01-01
• Device Publish Date: 2023-12-22

On-Brand Devices [Amplivox ]

• 05060488901386: Otowave 302
• 05060488901171: Model 116
• 05060488901164: Model 170
• 05060488901102: Model 270
• 05060488901034: Model 240
• 05060488901027: Model 260
• 05060488901010: Otowave 102
• 05060488901003: Otowave 202
• 05060488902949: modelONE
• 05060488902680: Otowave 302+
• 05060488902635: Otowave 102-C
• 05060488901645: Model 270+
• 05060488901409: Otosure
• 05060488901157: PC850