NanoVi 4800-00-W

GUDID 00850005614043

ENG3 CORPORATION

Non-heated respiratory humidifier

• Primary Device ID: 00850005614043
• NIH Device Record Key: 886d87fc-30f2-4f99-8e5d-5687a4a503af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NanoVi
• Version Model Number: NanoVi Pro Wellness
• Catalog Number: 4800-00-W
• 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	00850005614043 [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