Oh’Care Lite Blood Glucose Test strips INFS003L

GUDID 00860396000615

Blood Glucose Test strips

IJDREAM CORPORATION

Glucose IVD, kit, electrometry
Primary Device ID00860396000615
NIH Device Record Key7aa217aa-d264-4af6-b345-16a67c24998d
Commercial Distribution StatusIn Commercial Distribution
Brand NameOh’Care Lite Blood Glucose Test strips
Version Model NumberIGM-1003A
Catalog NumberINFS003L
Company DUNS081064046
Company NameIJDREAM CORPORATION
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 Usetrue
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

Phone800-925-2949
Emailsupport@ijdream.com
Phone800-925-2949
Emailsupport@ijdream.com
Phone800-925-2949
Emailsupport@ijdream.com
Phone800-925-2949
Emailsupport@ijdream.com
Phone800-925-2949
Emailsupport@ijdream.com
Phone800-925-2949
Emailsupport@ijdream.com
Phone800-925-2949
Emailsupport@ijdream.com
Phone800-925-2949
Emailsupport@ijdream.com
Phone800-925-2949
Emailsupport@ijdream.com
Phone800-925-2949
Emailsupport@ijdream.com
Phone800-925-2949
Emailsupport@ijdream.com
Phone800-925-2949
Emailsupport@ijdream.com
Phone800-925-2949
Emailsupport@ijdream.com
Phone800-925-2949
Emailsupport@ijdream.com

Device Dimensions

Total Volume0.5 Microliter
Total Volume0.5 Microliter
Total Volume0.5 Microliter
Total Volume0.5 Microliter
Total Volume0.5 Microliter
Total Volume0.5 Microliter
Total Volume0.5 Microliter
Total Volume0.5 Microliter
Total Volume0.5 Microliter
Total Volume0.5 Microliter
Total Volume0.5 Microliter
Total Volume0.5 Microliter
Total Volume0.5 Microliter
Total Volume0.5 Microliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 36 Percent (%) Relative Humidity and 86 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 36 Percent (%) Relative Humidity and 86 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 36 Percent (%) Relative Humidity and 86 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 36 Percent (%) Relative Humidity and 86 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 36 Percent (%) Relative Humidity and 86 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 36 Percent (%) Relative Humidity and 86 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 36 Percent (%) Relative Humidity and 86 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 36 Percent (%) Relative Humidity and 86 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 36 Percent (%) Relative Humidity and 86 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 36 Percent (%) Relative Humidity and 86 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 36 Percent (%) Relative Humidity and 86 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 36 Percent (%) Relative Humidity and 86 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 36 Percent (%) Relative Humidity and 86 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 36 Percent (%) Relative Humidity and 86 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100860396000615 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LFRGlucose Dehydrogenase, Glucose

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-12-05
Device Publish Date2018-06-30

Devices Manufactured by IJDREAM CORPORATION

00860313000933 - Oh'Care Lite2023-04-10 Glucose Control Solution Level 2
00850002937428 - ijCare2020-03-09
00860313000919 - Oh’Care Lite Blood Glucose Monitoring System for Self-Testing2019-12-05 Blood Glucose Monitoring System for Self-Testing
00860396000615 - Oh’Care Lite Blood Glucose Test strips2019-12-05Blood Glucose Test strips
00860396000615 - Oh’Care Lite Blood Glucose Test strips2019-12-05 Blood Glucose Test strips
00860396000608 - ijCare2019-05-31

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