OKRA Glucose monitoring system starter kit

GUDID 08809115905703

blood glucose monitoring system for self-testing starter kit

OSANG HEALTHCARE Co., Ltd.

Glucose monitoring system IVD, home-use

• Primary Device ID: 08809115905703
• NIH Device Record Key: c20aa96f-77b7-4ffe-aa64-fcb23f8670f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OKRA Glucose monitoring system starter kit
• Version Model Number: IGM-1003A
• Company DUNS: 688195374
• Company Name: OSANG HEALTHCARE Co., Ltd.
• 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: false
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809115905703 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132966

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: 2020-11-06
• Device Publish Date: 2020-10-29

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