Oh'Care Lite INFCN003L

GUDID 00860313000933

Glucose Control Solution Level 2

IJDREAM CORPORATION

Glucose monitoring system IVD, home-use

• Primary Device ID: 00860313000933
• NIH Device Record Key: 21071d41-125c-459c-b3e5-22d9add7cb12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oh'Care Lite
• Version Model Number: Oh'Care Lite Control Solution
• Catalog Number: INFCN003L
• Company DUNS: 081064046
• Company Name: IJDREAM 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: 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860313000933 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132966

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)
• LFR: Glucose Dehydrogenase, Glucose

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: 2023-04-10
• Device Publish Date: 2023-03-31