SD GlucoNavii Blood Glucose Monitoring System

GUDID 00887473000016

SD Biosensor, Inc.

Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use

• Primary Device ID: 00887473000016
• NIH Device Record Key: c48f9db7-c655-4f27-a3f9-5665d5004341
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SD GlucoNavii Blood Glucose Monitoring System
• Version Model Number: 01GM11
• Company DUNS: 557812789
• Company Name: SD Biosensor, 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887473000016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100398

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-03-23

On-Brand Devices [SD GlucoNavii Blood Glucose Monitoring System]

• 00887473000108: 01GC110
• 00887473000016: 01GM11
• 00887473000009: 01GC111