Precision Xceed Pro 70907-03

GUDID 00357599000189

Precision Xceed Pro Blood Glucose and ß-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
Primary Device ID00357599000189
NIH Device Record Key76fc003a-8a87-49a3-b347-ba8649271226
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrecision Xceed Pro
Version Model Number70907-03
Catalog Number70907-03
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1(877)529-7185
Emailxx@xx.xx
Phone+1(877)529-7185
Emailxx@xx.xx
Phone+1(877)529-7185
Emailxx@xx.xx
Phone+1(877)529-7185
Emailxx@xx.xx
Phone+1(877)529-7185
Emailxx@xx.xx
Phone+1(877)529-7185
Emailxx@xx.xx
Phone+1(877)529-7185
Emailxx@xx.xx
Phone+1(877)529-7185
Emailxx@xx.xx
Phone+1(877)529-7185
Emailxx@xx.xx
Phone+1(877)529-7185
Emailxx@xx.xx
Phone+1(877)529-7185
Emailxx@xx.xx
Phone+1(877)529-7185
Emailxx@xx.xx
Phone+1(877)529-7185
Emailxx@xx.xx
Phone+1(877)529-7185
Emailxx@xx.xx
Phone+1(877)529-7185
Emailxx@xx.xx
Phone+1(877)529-7185
Emailxx@xx.xx
Phone+1(877)529-7185
Emailxx@xx.xx
Phone+1(877)529-7185
Emailxx@xx.xx
Phone+1(877)529-7185
Emailxx@xx.xx
Phone+1(877)529-7185
Emailxx@xx.xx
Phone+1(877)529-7185
Emailxx@xx.xx
Phone+1(877)529-7185
Emailxx@xx.xx
Phone+1(877)529-7185
Emailxx@xx.xx
Phone+1(877)529-7185
Emailxx@xx.xx
Phone+1(877)529-7185
Emailxx@xx.xx
Phone+1(877)529-7185
Emailxx@xx.xx
Phone+1(877)529-7185
Emailxx@xx.xx
Phone+1(877)529-7185
Emailxx@xx.xx
Phone+1(877)529-7185
Emailxx@xx.xx
Phone+1(877)529-7185
Emailxx@xx.xx
Phone+1(877)529-7185
Emailxx@xx.xx
Phone+1(877)529-7185
Emailxx@xx.xx
Phone+1(877)529-7185
Emailxx@xx.xx
Phone+1(877)529-7185
Emailxx@xx.xx
Phone+1(877)529-7185
Emailxx@xx.xx
Phone+1(877)529-7185
Emailxx@xx.xx

Operating and Storage Conditions

Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100357599000189 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LFRGlucose dehydrogenase, glucose

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-12-11
Device Publish Date2016-08-12

On-Brand Devices [Precision Xceed Pro]

00357599000257Precision Xceed Pro
00357599000189Precision Xceed Pro Blood Glucose and ß-Ketone Monitoring System
00357599000158Precision Xceed Pro Blood Glucose and ß-Ketone Monitoring System
00357599000134Precision Xceed Pro Blood Glucose and ß-Ketone Monitoring System
35021791709350Precision Xceed Pro Blood ß-Ketone Test Strips
30093815709320Precision Xceed Pro Blood Glucose Test Strips

Trademark Results [Precision Xceed Pro]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PRECISION XCEED PRO
PRECISION XCEED PRO
77225761 3437436 Live/Registered
Abbott Laboratories
2007-07-10

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