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

GUDID 00793150629770

Blood Glucose Monitoring System for Self-Testing

OSANG HEALTHCARE Co., Ltd.

Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use

• Primary Device ID: 00793150629770
• NIH Device Record Key: 1d2dafd6-c082-44eb-bec6-976c146a5c25
• 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: 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00793150629770 [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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