Amplivox

GUDID 05060488901003

AMPLIVOX LIMITED

Impedance audiometer Impedance audiometer Impedance audiometer Impedance audiometer Impedance audiometer Impedance audiometer Impedance audiometer Impedance audiometer Impedance audiometer Impedance audiometer Impedance audiometer Impedance audiometer Impedance audiometer Impedance audiometer Impedance audiometer Impedance audiometer Impedance audiometer Impedance audiometer

• Primary Device ID: 05060488901003
• NIH Device Record Key: 0a48e9ab-9874-4d34-ae9d-9a3c04ee8813
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amplivox
• Version Model Number: Otowave 202
• 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	05060488901003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150163

FDA Product Code

• NAS: Tympanometer

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: 2018-10-08
• Device Publish Date: 2016-09-24

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