Oh’Care Lite Blood Glucose Monitoring System Kit

GUDID 00793150629763

Glucose monitoring system IVD, home-use

Primary Device ID	00793150629763
NIH Device Record Key	5eae7889-4315-4c18-9211-4b6e87be97d1
Commercial Distribution Status	In Commercial Distribution
Brand Name	Oh’Care Lite Blood Glucose Monitoring System Kit
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	true
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

Device Issuing Agency	Device ID
GS1	00793150629763 [Primary]

JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)

Steralize Prior To Use	false
Device Is Sterile	false

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