FreeStyle Precision Pro 71288

GUDID 30093815712887

FreeStyle Precision Pro Blood ß-Ketone Test Strips

ABBOTT DIABETES CARE INC

Multiple clinical chemistry analyte monitoring system IVD, point-of-care
Primary Device ID30093815712887
NIH Device Record Key4478ff9c-b178-45bb-ab61-81f3ada15082
Commercial Distribution StatusIn Commercial Distribution
Brand NameFreeStyle Precision Pro
Version Model Number71288
Catalog Number71288
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(877)529-7185
Emailxx@xx.xx

Operating and Storage Conditions

Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100093815712886 [Primary]
GS110093815712883 [Unit of Use]
GS130093815712887 [Package]
Contains: 00093815712886
Package: Case [12 Units]
In Commercial Distribution
NDC/NHRIC57599-1288-4 [Secondary]

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 Number7
Public Version Date2019-12-11
Device Publish Date2016-08-12

On-Brand Devices [FreeStyle Precision Pro]

00093815714125FreeStyle Precision Pro Blood Glucose and ß-Ketone Monitoring System
00093815714118FreeStyle Precision Pro Blood Glucose and ß-Ketone Monitoring System
30093815712887FreeStyle Precision Pro Blood ß-Ketone Test Strips
30093815712849FreeStyle Precision Pro Blood Glucose Test Strips
00357599815004FreeStyle Precision Pro Blood Glucose and ß-Ketone Monitoring System

Trademark Results [FreeStyle Precision Pro]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FREESTYLE PRECISION PRO
FREESTYLE PRECISION PRO
86154681 4809352 Live/Registered
Abbott Diabetes Care Inc.
2013-12-30
FREESTYLE PRECISION PRO
FREESTYLE PRECISION PRO
85053174 not registered Dead/Abandoned
Abbott Diabetes Care Inc.
2010-06-02

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