On Call Express Blood Glucose Monitoring System

GUDID 00682607000074

Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G)

ACON LABORATORIES, INC.

Home-use/point-of-care blood glucose monitoring system IVD
Primary Device ID00682607000074
NIH Device Record Keyd5fe2978-9b9d-43c9-9333-564b8ba32f9c
Commercial Distribution StatusIn Commercial Distribution
Brand NameOn Call Express Blood Glucose Monitoring System
Version Model NumberG115-10D
Company DUNS781100966
Company NameACON LABORATORIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
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

Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100682607000074 [Direct Marking]
GS100682607557158 [Primary]
GS100682607557165 [Primary]
GS110682607557155 [Package]
Contains: 00682607557158
Package: case [4 Units]
In Commercial Distribution
GS110682607557162 [Package]
Contains: 00682607557165
Package: case [4 Units]
In Commercial Distribution
GS120682607557152 [Package]
Contains: 10682607557155
Package: carton [6 Units]
In Commercial Distribution
GS120682607557169 [Package]
Contains: 10682607557162
Package: carton [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJXSingle (specified) analyte controls (assayed and unassayed)
NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

Devices Manufactured by ACON LABORATORIES, INC.

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