VivaGuard Ino Smart

GUDID 00853483008243

VivaGuard Ino Smart Blood Glucose Meter

Able Diagnostics Inc

Glucose IVD, kit, electrometry

• Primary Device ID: 00853483008243
• NIH Device Record Key: 8cea1f9f-d807-49a8-9af5-c572e4c3d0a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VivaGuard Ino Smart
• Version Model Number: VGM04
• Company DUNS: 080952036
• Company Name: Able Diagnostics 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: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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	00853483008243 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173140

FDA Product Code

• NBW: System, Test, Blood Glucose, Over The Counter

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: 2021-02-11
• Device Publish Date: 2021-02-03

On-Brand Devices [VivaGuard Ino Smart]

• 00853483008243: VivaGuard Ino Smart Blood Glucose Meter
• 00853483008236: VivaGuard Ino Smart Blood Glucose Meter Only Kit