ijCare

GUDID 00850002937428

IJDREAM CORPORATION

Glucose monitoring system IVD, home-use

• Primary Device ID: 00850002937428
• NIH Device Record Key: 7d74943b-3396-4ff0-863e-7488af0792eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ijCare
• Version Model Number: ijCare Blood Glucose Monitoring System Kit
• 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	00850002937428 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132966

FDA Product Code

• 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: 2020-03-09
• Device Publish Date: 2020-02-28

On-Brand Devices [ijCare]

• 00860396000608: ijCare Blood Glucose Monitoring System Kit
• 00850002937428: ijCare Blood Glucose Monitoring System Kit