NanoVi 4900-00

GUDID 00850005614050

ENG3 CORPORATION

Non-heated respiratory humidifier Room humidifier Room humidifier Room humidifier Room humidifier Room humidifier Room humidifier Room humidifier Room humidifier Room humidifier Room humidifier Room humidifier Room humidifier Room humidifier Room humidifier

• Primary Device ID: 00850005614050
• NIH Device Record Key: ff079910-787e-41c2-a347-b2b494add72d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NanoVi
• Version Model Number: NanoVi Exo
• Catalog Number: 4900-00
• Company DUNS: 016991764
• Company Name: ENG3 CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850005614050 [Primary]

FDA Product Code

• KFZ: Humidifier, Non-Direct Patient Interface (Home-Use)

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: 2019-03-11
• Device Publish Date: 2019-02-25

On-Brand Devices [NanoVi]

• 00850005614067: NanoVi Exo Wellness
• 00850005614050: NanoVi Exo
• 00850005614043: NanoVi Pro Wellness
• 00850005614036: NanoVi Pro
• 00850005614029: NanoVi Eco Wellness
• 00850005614012: NanoVi Eco