Precision Xtra 71502

GUDID 30093815715024

Precision Xtra Blood Glucose & Ketone Monitoring System

ABBOTT DIABETES CARE INC

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 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 ID30093815715024
NIH Device Record Key59ed128b-7c30-4e23-9d48-3d45b6bbe957
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrecision Xtra
Version Model Number71502
Catalog Number71502
Company DUNS966390890
Company NameABBOTT DIABETES CARE 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)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx
Phone+1(800)527-3339
Emailxx@xx.xx

Operating and Storage Conditions

Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100093815715023 [Primary]
GS130093815715024 [Package]
Contains: 00093815715023
Package: Case [4 Units]
In Commercial Distribution
NDC/NHRIC57599-1502-1 [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 Number5
Public Version Date2019-12-11
Device Publish Date2016-08-12

On-Brand Devices [Precision Xtra]

30093815998786Precision Xtra Blood Glucose Test Strips
30093815998779Precision Xtra Blood Glucose Test Strips
30093815998380Precision Xtra Blood Glucose Test Strips
30093815998373Precision Xtra Blood Glucose & Ketone Monitoring System
40093815997281Precision Xtra Blood Glucose Test Strips
30093815996959Precision Xtra Blood Glucose Test Strips
30093815996942Precision Xtra Blood Glucose Test Strips
30093815988145Precision Xtra Blood Glucose & Ketone Monitoring System
30093815800508Precision Xtra Blood Glucose Test Strips
30093815715024Precision Xtra Blood Glucose & Ketone Monitoring System
30093815707463Precision Xtra Blood ß-Ketone Test Strips
30093815707456Precision Xtra Blood ß-Ketone Test Strips

Trademark Results [Precision Xtra]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PRECISION XTRA
PRECISION XTRA
77952020 3935672 Live/Registered
Abbott Laboratories
2010-03-05
PRECISION XTRA
PRECISION XTRA
77065423 3293222 Live/Registered
Abbott Laboratories
2006-12-15

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