FDA.reportPublic FDA data

Oh’Care Lite Blood Glucose Monitoring System Kit

Primary DI
00793150629763
Brand
Oh’Care Lite Blood Glucose Monitoring System Kit
Company
OSANG HEALTHCARE Co., Ltd.
Model
IGM-1003A
Device description
Blood Glucose Monitoring System Kit
Published
2017-11-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
LFRGlucose Dehydrogenase, Glucose
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1
LFRGlucose Dehydrogenase, GlucoseClinical Chemistry2
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132966000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132966000GLUNEO LITE GLUCOSE MONITORING SYSTEM, GLUNEO LITE PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEMInfopia Co, Ltd.2013-12-05NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00793150629763PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00793150629763007931506297637931506297630793150629763

GMDN Terms#

Term, Definition table
TermDefinition
Glucose monitoring system IVD, home-useA collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume0.5Microliter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-925-2949support@ijdream.com

Regulatory Flags#

DUNS number
688195374
Device count
1
Kit
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809115905796Oh'care Lite Smart Glucose Test StripIGM-1003F2020-11-05
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08809115908957Element™Plus Test StripsIGM-0021B2017-07-21
08809115905369OKRA Glucose Test Strip(25T)IGM-1003A2021-07-27
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08809115906540Oh'Care Lite Smart Glucose Test StripIGM-1003F2019-09-17
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08809115904119CURO L5 Glucose test stripILM-0001AINFSG001EF2022-09-26
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