Oh’Care Lite Glucose Control Solution INFCN003L

GUDID 00793150629794

Glucose Control Solution

OSANG HEALTHCARE Co., Ltd.

Glucose IVD, control

• Primary Device ID: 00793150629794
• NIH Device Record Key: 83c357a1-72b9-433f-ad58-dc4903183d56
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oh’Care Lite Glucose Control Solution
• Version Model Number: IGM-1003A
• Catalog Number: INFCN003L
• 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: 800-925-2949
• Email: support@ijdream.com
• Phone: 800-925-2949
• Email: support@ijdream.com
• Phone: 800-925-2949
• Email: support@ijdream.com
• Phone: 800-925-2949
• Email: support@ijdream.com
• Phone: 800-925-2949
• Email: support@ijdream.com
• Phone: 800-925-2949
• Email: support@ijdream.com
• Phone: 800-925-2949
• Email: support@ijdream.com
• Phone: 800-925-2949
• Email: support@ijdream.com
• Phone: 800-925-2949
• Email: support@ijdream.com
• Phone: 800-925-2949
• Email: support@ijdream.com
• Phone: 800-925-2949
• Email: support@ijdream.com
• Phone: 800-925-2949
• Email: support@ijdream.com
• Phone: 800-925-2949
• Email: support@ijdream.com
• Phone: 800-925-2949
• Email: support@ijdream.com
• Phone: 800-925-2949
• Email: support@ijdream.com
• Phone: 800-925-2949
• Email: support@ijdream.com
• Phone: 800-925-2949
• Email: support@ijdream.com
• Phone: 800-925-2949
• Email: support@ijdream.com
• Phone: 800-925-2949
• Email: support@ijdream.com
• Phone: 800-925-2949
• Email: support@ijdream.com
• Phone: 800-925-2949
• Email: support@ijdream.com
• Phone: 800-925-2949
• Email: support@ijdream.com
• Phone: 800-925-2949
• Email: support@ijdream.com
• Phone: 800-925-2949
• Email: support@ijdream.com
• Phone: 800-925-2949
• Email: support@ijdream.com
• Phone: 800-925-2949
• Email: support@ijdream.com
• Phone: 800-925-2949
• Email: support@ijdream.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00793150629794 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132966

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: 2020-10-02
• Device Publish Date: 2020-09-24

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