Glucose Pilot 10001

GUDID 00748349000717

Glucose Pilot - The Complete Glucose Monitoring System

SYNTRON BIORESEARCH, INC.

Blood glucose/blood pressure monitoring system, home-use Blood glucose/blood pressure monitoring system, home-use Blood glucose/blood pressure monitoring system, home-use Blood glucose/blood pressure monitoring system, home-use Blood glucose/blood pressure monitoring system, home-use Blood glucose/blood pressure monitoring system, home-use Blood glucose/blood pressure monitoring system, home-use Blood glucose/blood pressure monitoring system, home-use Blood glucose/blood pressure monitoring system, home-use Blood glucose/blood pressure monitoring system, home-use Blood glucose/blood pressure monitoring system, home-use Blood glucose/blood pressure monitoring system, home-use Blood glucose/blood pressure monitoring system, home-use Blood glucose/blood pressure monitoring system, home-use

• Primary Device ID: 00748349000717
• NIH Device Record Key: a10c9506-0061-436e-8bf2-53b3b69a52d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Glucose Pilot
• Version Model Number: 10001
• Catalog Number: 10001
• Company DUNS: 174517060
• Company Name: SYNTRON BIORESEARCH, 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: false
• 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	00748349000717 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052208

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: 2020-08-19
• Device Publish Date: 2020-08-11

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