AimStrip Tandem blood glucose test strips

GUDID 00695684775506

AimStrip Tandem blood glucose test strips

OSANG HEALTHCARE Co., Ltd.

Glucose IVD, kit, electrometry
Primary Device ID00695684775506
NIH Device Record Key5db1f632-16e6-450c-8dc5-baccdc068d48
Commercial Distribution StatusIn Commercial Distribution
Brand NameAimStrip Tandem blood glucose test strips
Version Model NumberILM-0001A
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-854-8446
Emailsales@germainelabs.com
Phone1-800-854-8446
Emailsales@germainelabs.com
Phone1-800-854-8446
Emailsales@germainelabs.com
Phone1-800-854-8446
Emailsales@germainelabs.com
Phone1-800-854-8446
Emailsales@germainelabs.com
Phone1-800-854-8446
Emailsales@germainelabs.com
Phone1-800-854-8446
Emailsales@germainelabs.com
Phone1-800-854-8446
Emailsales@germainelabs.com
Phone1-800-854-8446
Emailsales@germainelabs.com
Phone1-800-854-8446
Emailsales@germainelabs.com
Phone1-800-854-8446
Emailsales@germainelabs.com
Phone1-800-854-8446
Emailsales@germainelabs.com
Phone1-800-854-8446
Emailsales@germainelabs.com
Phone1-800-854-8446
Emailsales@germainelabs.com
Phone1-800-854-8446
Emailsales@germainelabs.com
Phone1-800-854-8446
Emailsales@germainelabs.com
Phone1-800-854-8446
Emailsales@germainelabs.com
Phone1-800-854-8446
Emailsales@germainelabs.com
Phone1-800-854-8446
Emailsales@germainelabs.com
Phone1-800-854-8446
Emailsales@germainelabs.com
Phone1-800-854-8446
Emailsales@germainelabs.com
Phone1-800-854-8446
Emailsales@germainelabs.com
Phone1-800-854-8446
Emailsales@germainelabs.com
Phone1-800-854-8446
Emailsales@germainelabs.com
Phone1-800-854-8446
Emailsales@germainelabs.com
Phone1-800-854-8446
Emailsales@germainelabs.com
Phone1-800-854-8446
Emailsales@germainelabs.com
Phone1-800-854-8446
Emailsales@germainelabs.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100695684775506 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CGAGlucose Oxidase, Glucose

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-23
Device Publish Date2020-03-13

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