FreeStyle Lite 70822

GUDID 40699073708227

FreeStyle Lite Blood Glucose Test Strips

ABBOTT DIABETES CARE INC

Glucose/ketone monitoring system IVD, home-use Glucose/ketone monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use
Primary Device ID40699073708227
NIH Device Record Keyb6708bc4-e6c2-4895-a8e8-64250c4efaa6
Commercial Distribution StatusIn Commercial Distribution
Brand NameFreeStyle Lite
Version Model Number70822
Catalog Number70822
Company DUNS966390890
Company NameABBOTT DIABETES CARE INC
Device Count50
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

Phone+1(888)522-5226
Emailxx@xx.xx
Phone+1(888)522-5226
Emailxx@xx.xx
Phone+1(888)522-5226
Emailxx@xx.xx
Phone+1(888)522-5226
Emailxx@xx.xx
Phone+1(888)522-5226
Emailxx@xx.xx
Phone+1(888)522-5226
Emailxx@xx.xx
Phone+1(888)522-5226
Emailxx@xx.xx
Phone+1(888)522-5226
Emailxx@xx.xx
Phone+1(888)522-5226
Emailxx@xx.xx
Phone+1(888)522-5226
Emailxx@xx.xx
Phone+1(888)522-5226
Emailxx@xx.xx
Phone+1(888)522-5226
Emailxx@xx.xx
Phone+1(888)522-5226
Emailxx@xx.xx
Phone+1(888)522-5226
Emailxx@xx.xx
Phone+1(888)522-5226
Emailxx@xx.xx
Phone+1(888)522-5226
Emailxx@xx.xx
Phone+1(888)522-5226
Emailxx@xx.xx
Phone+1(888)522-5226
Emailxx@xx.xx
Phone+1(888)522-5226
Emailxx@xx.xx
Phone+1(888)522-5226
Emailxx@xx.xx
Phone+1(888)522-5226
Emailxx@xx.xx
Phone+1(888)522-5226
Emailxx@xx.xx
Phone+1(888)522-5226
Emailxx@xx.xx
Phone+1(888)522-5226
Emailxx@xx.xx
Phone+1(888)522-5226
Emailxx@xx.xx
Phone+1(888)522-5226
Emailxx@xx.xx
Phone+1(888)522-5226
Emailxx@xx.xx
Phone+1(888)522-5226
Emailxx@xx.xx
Phone+1(888)522-5226
Emailxx@xx.xx
Phone+1(888)522-5226
Emailxx@xx.xx
Phone+1(888)522-5226
Emailxx@xx.xx
Phone+1(888)522-5226
Emailxx@xx.xx
Phone+1(888)522-5226
Emailxx@xx.xx
Phone+1(888)522-5226
Emailxx@xx.xx
Phone+1(888)522-5226
Emailxx@xx.xx
Phone+1(888)522-5226
Emailxx@xx.xx
Phone+1(888)522-5226
Emailxx@xx.xx

Operating and Storage Conditions

Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100699073708229 [Primary]
GS110699073708226 [Unit of Use]
GS130699073708220 [Package]
Contains: 00699073708229
Package: Case [12 Units]
In Commercial Distribution
GS140699073708227 [Package]
Contains: 00699073708229
Package: Case [12 Units]
In Commercial Distribution
NDC/NHRIC99073-0708-22 [Secondary]

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 Date2016-07-22

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Trademark Results [FreeStyle Lite]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FREESTYLE LITE
FREESTYLE LITE
77384230 3488499 Live/Registered
Abbott Diabetes Care Inc.
2008-01-30
FREESTYLE LITE
FREESTYLE LITE
77023119 3427434 Live/Registered
Abbott Diabetes Care Inc.
2006-10-17
FREESTYLE LITE
FREESTYLE LITE
77022004 not registered Dead/Abandoned
Abbott Laboratories
2006-10-16

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