Integrity OAE Probe

GUDID 00627908010070

UG OAE probe 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

Otoacoustic emission system, battery-powered

• Primary Device ID: 00627908010070
• NIH Device Record Key: 8e2e3cd0-f3aa-4e5c-af05-888ef560a3db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integrity OAE Probe
• Version Model Number: P40-UG
• 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	00627908010070 [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 OAE Probe ]

• 00062790820121: UG OAE probe for use as an accessory with the second generation Integrity V500 system (DI: 00062
• 00062790820114: GP OAE probe for use as an accessory with the second generation Integrity V500 system (DI: 00062
• 00062790810078: UG OAE probe for use as an accessory with the first generation Integrity V500 system (DI: 00062
• 00062790810061: GP OAE probe for use as an accessory with the first generation Integrity V500 system (DI: 00062
• 00627908020123: UG OAE probe for use as an accessory with the second generation Integrity V500 system (DI: 00627
• 00627908020116: GP OAE probe for use as an accessory with the second generation Integrity V500 system (DI: 00627
• 00627908010070: UG OAE probe for use as an accessory with the first generation Integrity V500 system (DI: 00627
• 00627908010063: GP OAE probe for use as an accessory with the first generation Integrity V500 system (DI: 00627