OKRA Glucose meter

GUDID 08809115905727

blood glucose monitoring system for self-testing meter

OSANG HEALTHCARE Co., Ltd.

Glucose monitoring system IVD, home-use

• Primary Device ID: 08809115905727
• NIH Device Record Key: 672152ec-853b-4365-888a-221b9b7885fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OKRA Glucose meter
• Version Model Number: IGM-1003A
• 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: 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: 1-833-977-1339
• Email: Support@okra.care
• Phone: 1-833-977-1339
• Email: Support@okra.care
• Phone: 1-833-977-1339
• Email: Support@okra.care
• Phone: 1-833-977-1339
• Email: Support@okra.care
• Phone: 1-833-977-1339
• Email: Support@okra.care
• Phone: 1-833-977-1339
• Email: Support@okra.care
• Phone: 1-833-977-1339
• Email: Support@okra.care
• Phone: 1-833-977-1339
• Email: Support@okra.care
• Phone: 1-833-977-1339
• Email: Support@okra.care
• Phone: 1-833-977-1339
• Email: Support@okra.care
• Phone: 1-833-977-1339
• Email: Support@okra.care
• Phone: 1-833-977-1339
• Email: Support@okra.care
• Phone: 1-833-977-1339
• Email: Support@okra.care
• Phone: 1-833-977-1339
• Email: Support@okra.care
• Phone: 1-833-977-1339
• Email: Support@okra.care
• Phone: 1-833-977-1339
• Email: Support@okra.care
• Phone: 1-833-977-1339
• Email: Support@okra.care
• Phone: 1-833-977-1339
• Email: Support@okra.care
• Phone: 1-833-977-1339
• Email: Support@okra.care
• Phone: 1-833-977-1339
• Email: Support@okra.care
• Phone: 1-833-977-1339
• Email: Support@okra.care
• Phone: 1-833-977-1339
• Email: Support@okra.care
• Phone: 1-833-977-1339
• Email: Support@okra.care
• Phone: 1-833-977-1339
• Email: Support@okra.care
• Phone: 1-833-977-1339
• Email: Support@okra.care
• Phone: 1-833-977-1339
• Email: Support@okra.care
• Phone: 1-833-977-1339
• Email: Support@okra.care
• Phone: 1-833-977-1339
• Email: Support@okra.care
• Phone: 1-833-977-1339
• Email: Support@okra.care
• Phone: 1-833-977-1339
• Email: Support@okra.care
• Phone: 1-833-977-1339
• Email: Support@okra.care
• Phone: 1-833-977-1339
• Email: Support@okra.care
• Phone: 1-833-977-1339
• Email: Support@okra.care
• Phone: 1-833-977-1339
• Email: Support@okra.care

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809115905727 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-11-06
• Device Publish Date: 2020-10-29

Devices Manufactured by OSANG HEALTHCARE Co., Ltd.

• 08809115900418 - QuickFinder™ COVID-19/Flu Antigen ProTest: 2025-03-26 25 Test Kit / Box
• 08809115900425 - QuickFinder™ COVID-19/Flu Antigen Self Test: 2025-03-26 5 Test Kit / Box
• 08809115900432 - QuickFinder™ COVID-19/Flu Antigen Self Test: 2025-03-26 4 Test Kit / Box
• 08809115900449 - QuickFinder™ COVID-19/Flu Antigen Self Test: 2025-03-26 2 Test Kit / Box
• 08809115900456 - QuickFinder™ COVID-19/Flu Antigen Self Test: 2025-03-25 1 Test Kit / Box
• 08809115900401 - QuickFinder™ COVID-19/Flu Antigen Pro Control Swab Kit: 2025-03-20 10 Sets / Box
• 08809115903297 - OHC COVID-19/ Flu Antigen Test Pro: 2024-05-20 25 Test / Kit
• 08809115904423 - QuickFinder™ COVID-19/Flu Antigen Self Test: 2024-05-20 2 Test / Kit