Integrity Insert Earphones

GUDID 00627908010049

ER-3A insert earphones for use as an accessory with the first generation Integrity V500 system (DI: 00627908010018). The UDI is comprised of the following: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)

Vivosonic Inc

Evoked-potential audiometer

• Primary Device ID: 00627908010049
• NIH Device Record Key: 257fd2ae-5497-4186-8f56-4ef4a42cc649
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integrity Insert Earphones
• Version Model Number: ER-3A-ABR
• 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	00627908010049 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-04-21
• Device Publish Date: 2016-09-23

On-Brand Devices [Integrity Insert Earphones ]

• 00062790820084: ER-3C insert earphones for use as an accessory with the second generation Integrity V500 system
• 00062790820077: ER-3A insert earphones for use as an accessory with the second generation Integrity V500 system
• 00062790820060: ER-2 insert earphones for use as an accessory with the second generation Integrity V500 system (
• 00062790810047: ER-3A insert earphones for use as an accessory with the first generation Integrity V500 system (
• 00627908020086: ER-3C insert earphones for use as an accessory with the second generation Integrity V500 system
• 00627908020079: ER-3A insert earphones for use as an accessory with the second generation Integrity V500 system
• 00627908020062: ER-2 insert earphones for use as an accessory with the second generation Integrity V500 system (
• 00627908010049: ER-3A insert earphones for use as an accessory with the first generation Integrity V500 system (