Oh’Care Lite Blood Glucose Monitoring System for Self-Testing INFM003L

GUDID 00860313000919

Blood Glucose Monitoring System for Self-Testing

IJDREAM CORPORATION

Glucose monitoring system IVD, home-use

• Primary Device ID: 00860313000919
• NIH Device Record Key: dbe925f2-8b06-42cb-9a93-00b66fda5b7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oh’Care Lite Blood Glucose Monitoring System for Self-Testing
• Version Model Number: IGM-1003A
• Catalog Number: INFM003L
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• 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 Dimensions

• Total Volume: 0.5 Microliter
• Total Volume: 0.5 Microliter
• Total Volume: 0.5 Microliter
• Total Volume: 0.5 Microliter
• Total Volume: 0.5 Microliter
• Total Volume: 0.5 Microliter
• Total Volume: 0.5 Microliter
• Total Volume: 0.5 Microliter
• Total Volume: 0.5 Microliter
• Total Volume: 0.5 Microliter
• Total Volume: 0.5 Microliter
• Total Volume: 0.5 Microliter
• Total Volume: 0.5 Microliter
• Total Volume: 0.5 Microliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860313000919 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-12-05
• Device Publish Date: 2018-06-30

Devices Manufactured by IJDREAM CORPORATION

• 00860313000933 - Oh'Care Lite: 2023-04-10 Glucose Control Solution Level 2
• 00850002937428 - ijCare: 2020-03-09
• 00860313000919 - Oh’Care Lite Blood Glucose Monitoring System for Self-Testing: 2019-12-05Blood Glucose Monitoring System for Self-Testing
• 00860313000919 - Oh’Care Lite Blood Glucose Monitoring System for Self-Testing: 2019-12-05 Blood Glucose Monitoring System for Self-Testing
• 00860396000615 - Oh’Care Lite Blood Glucose Test strips: 2019-12-05 Blood Glucose Test strips
• 00860396000608 - ijCare: 2019-05-31