PTS Panels eGLU™ Glucose Test Strips (12-ct) 2471

GUDID 00381932471015

PTS Panels eGLU™ glucose test strips are in vitro diagnostic devices used to monitor glucose levels in human whole blood. These test strips must be used in conjunction with a CardioChek Plus analyzer.

POLYMER TECHNOLOGY SYSTEMS, INC.

Glucose/ketone/lipid profile IVD, kit, multiple technologies
Primary Device ID00381932471015
NIH Device Record Key82a98fe6-b649-4520-98b5-f1411e5193f5
Commercial Distribution StatusIn Commercial Distribution
Brand NamePTS Panels eGLU™ Glucose Test Strips (12-ct)
Version Model Number2471
Catalog Number2471
Company DUNS835772872
Company NamePOLYMER TECHNOLOGY SYSTEMS, INC.
Device Count12
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-Countertrue

Customer Support Contacts

Phone+1(888)870-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)870-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100381932471015 [Primary]
GS110381932471012 [Unit of Use]

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 Date2019-10-23
Device Publish Date2019-10-15

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