VivaGuard Ino VGM01-371

GUDID 00853483008007

VivaGuard Ino Blood Glucose Monitoring System

Able Diagnostics Inc

Glucose IVD, kit, electrometry

• Primary Device ID: 00853483008007
• NIH Device Record Key: c173e62b-15ca-41e4-bf77-469bc2701dcb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VivaGuard Ino
• Version Model Number: VGM01
• Catalog Number: VGM01-371
• 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: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• 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	00853483008007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160179

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: 2021-02-10
• Device Publish Date: 2021-02-02

On-Brand Devices [VivaGuard Ino]

• 00853483008151: VivaGuard Ino Blood Glucose Meter
• 00853483008052: VivaGuard Ino Blood Glucose Meter Only Kit
• 00853483008014: VivaGuard Ino Test strips 50s (25s/vial)
• 00853483008007: VivaGuard Ino Blood Glucose Monitoring System
• 00853483008199: VivaGuard Ino Control Solution (1 & 3)
• 00853483008182: VivaGuard Ino Test strips 50s (50s/vial)
• 00853483008175: VivaGuard Ino Control Solution 2 (1 bottle/kit)
• 00853483008076: VivaGuard Ino Control Solution (L, M, H, 1 bottle/each)