FreeStyle Precision Neo 75175

GUDID 30093815751756

FreeStyle Precision Neo Blood Glucose 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 ID30093815751756
NIH Device Record Key0ad425d9-dc3d-4e2f-8510-6287a62c76be
Commercial Distribution StatusIn Commercial Distribution
Brand NameFreeStyle Precision Neo
Version Model Number75175
Catalog Number75175
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 Usetrue
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

Operating and Storage Conditions

Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100093815751755 [Primary]
GS130093815751756 [Package]
Contains: 00093815751755
Package: Case [4 Units]
In Commercial Distribution
GS140093815751753 [Package]
Contains: 00093815751755
Package: Case [4 Units]
In Commercial Distribution
NDC/NHRIC57599-5175-1 [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 Number3
Public Version Date2018-07-06
Device Publish Date2016-08-12

On-Brand Devices [FreeStyle Precision Neo]

30357599000357FreeStyle Precision Neo Blood Glucose Test Strips
30357599000340FreeStyle Precision Neo Blood Glucose Test Strips
30357599000333FreeStyle Precision Neo Blood Glucose Test Strips Not For Retail Sale
30357599000302FreeStyle Precision Neo Blood Glucose Monitoring System Not For Retail Sale
30093815751756FreeStyle Precision Neo Blood Glucose Monitoring System
30093815715819FreeStyle Precision Neo Blood Glucose Test Strips
30093815715796FreeStyle Precision Neo Blood Glucose Test Strips
30093815715772FreeStyle Precision Neo Blood Glucose Test Strips

Trademark Results [FreeStyle Precision Neo]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FREESTYLE PRECISION NEO
FREESTYLE PRECISION NEO
85765080 4881888 Live/Registered
Abbott Diabetes Care Inc.
2012-10-26
FREESTYLE PRECISION NEO
FREESTYLE PRECISION NEO
85600355 4889772 Live/Registered
Abbott Diabetes Care Inc.
2012-04-17

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