On Call Vivid Pal Blood Glucose Monitoring System

GUDID 00682607001057

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 ID00682607001057
NIH Device Record Key06be6052-09de-43cc-a1a6-12247207b8b3
Commercial Distribution StatusIn Commercial Distribution
Brand NameOn Call Vivid Pal Blood Glucose Monitoring System
Version Model NumberG115-107
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

Operating and Storage Conditions

Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
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 HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
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 HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
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 HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
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 HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
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 HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
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 HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
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 HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
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 HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
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 HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
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 HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
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 HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
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 HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
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 HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
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 HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
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 HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
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 HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
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 HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
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 HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
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 HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
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 HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
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 HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
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 HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
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 HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
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 HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
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 HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
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 HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
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 HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
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 HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
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 HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
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 HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100682607001057 [Direct Marking]
GS100682607558117 [Primary]
GS100682607558155 [Primary]
GS110682607558114 [Package]
Contains: 00682607558117
Package: case [4 Units]
In Commercial Distribution
GS110682607558152 [Package]
Contains: 00682607558155
Package: case [4 Units]
In Commercial Distribution
GS120682607558111 [Package]
Contains: 10682607558114
Package: carton [6 Units]
In Commercial Distribution
GS120682607558159 [Package]
Contains: 10682607558152
Package: carton [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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

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