LipidPlus® Meter

GUDID 10763924550507

Lipid and Glucose Measuring System

JANT PHARMACAL CORPORATION

Glycated haemoglobin (HbA1c) monitoring system IVD, home-use

• Primary Device ID: 10763924550507
• NIH Device Record Key: 9162d105-0f41-4cbc-a103-a37397979360
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LipidPlus® Meter
• Version Model Number: MD550
• Company DUNS: 797393659
• Company Name: JANT PHARMACAL CORPORATION
• 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: 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

Operating and Storage Conditions

• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	10763924550507 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130295

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-27
• Device Publish Date: 2017-02-16

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