FDA.reportPublic FDA data

Oh’Care Lite Blood Glucose Test strips

Primary DI
00860396000615
Brand
Oh’Care Lite Blood Glucose Test strips
Company
IJDREAM CORPORATION
Model
IGM-1003A
Catalog number
INFS003L
Device description
Blood Glucose Test strips
Published
2018-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LFRGlucose Dehydrogenase, Glucose
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
00860396000615PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860396000615008603960006158603960006150860396000615

GMDN Terms#

Term, Definition table
TermDefinition
Glucose IVD, kit, electrometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an electrometry method.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature36 Percent (%) Relative Humidity86 Percent (%) Relative Humidity

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
081064046
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860313000933Oh'Care LiteOh'Care Lite Control SolutionINFCN003L2023-03-31
00850002937428ijCareijCare Blood Glucose Monitoring System Kit2020-02-28
00860396000608ijCareijCare Blood Glucose Monitoring System Kit2019-05-23
00860313000919Oh’Care Lite Blood Glucose Monitoring System for Self-TestingIGM-1003AINFM003L2018-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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04719869706928Tyson Bio AC500 PRO Glucose Control Solution (Level 1 & Level 3)TYSON BIORESEARCH INC.NBW2026-07-13
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04719869706997medisana BG 150 Control Solution (Level 2)TYSON BIORESEARCH INC.NBW2026-07-13
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20612479280537McKessonMCKESSON MEDICAL-SURGICAL INC.LFR2025-12-01
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