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 ID08809115905727
NIH Device Record Key672152ec-853b-4365-888a-221b9b7885fe
Commercial Distribution StatusIn Commercial Distribution
Brand NameOKRA Glucose meter
Version Model NumberIGM-1003A
Company DUNS688195374
Company NameOSANG HEALTHCARE Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-833-977-1339
EmailSupport@okra.care
Phone1-833-977-1339
EmailSupport@okra.care
Phone1-833-977-1339
EmailSupport@okra.care
Phone1-833-977-1339
EmailSupport@okra.care
Phone1-833-977-1339
EmailSupport@okra.care
Phone1-833-977-1339
EmailSupport@okra.care
Phone1-833-977-1339
EmailSupport@okra.care
Phone1-833-977-1339
EmailSupport@okra.care
Phone1-833-977-1339
EmailSupport@okra.care
Phone1-833-977-1339
EmailSupport@okra.care
Phone1-833-977-1339
EmailSupport@okra.care
Phone1-833-977-1339
EmailSupport@okra.care
Phone1-833-977-1339
EmailSupport@okra.care
Phone1-833-977-1339
EmailSupport@okra.care
Phone1-833-977-1339
EmailSupport@okra.care
Phone1-833-977-1339
EmailSupport@okra.care
Phone1-833-977-1339
EmailSupport@okra.care
Phone1-833-977-1339
EmailSupport@okra.care
Phone1-833-977-1339
EmailSupport@okra.care
Phone1-833-977-1339
EmailSupport@okra.care
Phone1-833-977-1339
EmailSupport@okra.care
Phone1-833-977-1339
EmailSupport@okra.care
Phone1-833-977-1339
EmailSupport@okra.care
Phone1-833-977-1339
EmailSupport@okra.care
Phone1-833-977-1339
EmailSupport@okra.care
Phone1-833-977-1339
EmailSupport@okra.care
Phone1-833-977-1339
EmailSupport@okra.care
Phone1-833-977-1339
EmailSupport@okra.care
Phone1-833-977-1339
EmailSupport@okra.care
Phone1-833-977-1339
EmailSupport@okra.care
Phone1-833-977-1339
EmailSupport@okra.care
Phone1-833-977-1339
EmailSupport@okra.care
Phone1-833-977-1339
EmailSupport@okra.care
Phone1-833-977-1339
EmailSupport@okra.care

Device Identifiers

Device Issuing AgencyDevice ID
GS108809115905727 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NBWSystem, Test, Blood Glucose, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-06
Device Publish Date2020-10-29

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