Oh'Care Lite Smart Glucose control solution-Level 3

GUDID 08809115906533

blood glucose meter and test strip control solution-level 3

OSANG HEALTHCARE Co., Ltd.

Glucose IVD, control

• Primary Device ID: 08809115906533
• NIH Device Record Key: e56db837-5169-4587-9237-477a82c26ca4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oh'Care Lite Smart Glucose control solution-Level 3
• Version Model Number: IGM-1003F
• 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: false
• Serial Number: false
• 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

Customer Support Contacts

• Phone: 8773440474
• Email: info@indie-health.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809115906533 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182286

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-25
• Device Publish Date: 2019-09-17