Oh’Care Lite Blood Glucose Test strips INFS003L

GUDID 00793150629787

Blood Glucose Test strips

OSANG HEALTHCARE Co., Ltd.

Glucose IVD, kit, electrometry Glucose IVD, kit, electrometry

• Primary Device ID: 00793150629787
• NIH Device Record Key: 251f4139-28d6-40b7-8e82-216712ba54bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oh’Care Lite Blood Glucose Test strips
• Version Model Number: IGM-1003A
• Catalog Number: INFS003L
• 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: true
• 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: true

Customer Support Contacts

• Phone: 800-925-2949
• Email: support@ijdream.com
• Phone: 800-925-2949
• Email: support@ijdream.com

Device Dimensions

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

Operating and Storage Conditions

• Storage Environment Temperature: Between 36 Percent (%) Relative Humidity and 86 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Percent (%) Relative Humidity and 86 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00793150629787 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132966

FDA Product Code

• NBW: System, Test, Blood Glucose, Over The Counter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-11-03

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