EP Headphones

GUDID 00627908020178

Vivosonic Inc

Otoacoustic emission system, battery-powered

• Primary Device ID: 00627908020178
• NIH Device Record Key: 0088cde2-bff7-45bc-af3e-ecbb1e9f2dce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EP Headphones
• Version Model Number: H-802
• Company DUNS: 201740425
• Company Name: Vivosonic Inc
• 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	00627908020178 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043396

FDA Product Code

• EWO: Audiometer

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: 2023-06-16
• Device Publish Date: 2023-06-08

Devices Manufactured by Vivosonic Inc

• 00627908020192 - Bone Conductor: 2023-06-20
• 00627908020178 - EP Headphones: 2023-06-16
• 00627908020178 - EP Headphones: 2023-06-16
• 00627908020185 - ECochG Adapters: 2023-06-16
• 00627908020154 - Integrity VivoStim: 2020-05-12 Sound stimulator for use as an accessory with the second generation Integrity V500 system (DI: 00627908020017). The UDI is compr
• 00627908010018 - Integrity V500: 2020-04-21 Main handheld VivoLink unit for use with the first generation Integrity V500 system. The UDI is comprised of the following: GTI
• 00627908010025 - Integrity Amplitrode: 2020-04-21 One channel Amplitrode for use as an accessory with the first generation Integrity V500 system (DI: 00627908010018). The UDI i
• 00627908010032 - Integrity Bone Conductor: 2020-04-21 Bone conductor for use as an accessory with the first generation Integrity V500 system (DI: 00627908010018). The UDI is compris
• 00627908010049 - Integrity Insert Earphones: 2020-04-21 ER-3A insert earphones for use as an accessory with the first generation Integrity V500 system (DI: 00627908010018). The UDI i