FreeStyle Libre Pro 71687

GUDID 30357599716876

FreeStyle Libre Pro Reader Kit

ABBOTT DIABETES CARE INC

Percutaneous glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical
Primary Device ID30357599716876
NIH Device Record Key4a4f6acc-c89c-4bba-b267-134c85aac2cc
Commercial Distribution StatusIn Commercial Distribution
Brand NameFreeStyle Libre Pro
Version Model Number71687
Catalog Number71687
Company DUNS966390890
Company NameABBOTT DIABETES CARE INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(855)632-5297
Emailxx@xx.xx
Phone+1(855)632-5297
Emailxx@xx.xx
Phone+1(855)632-5297
Emailxx@xx.xx
Phone+1(855)632-5297
Emailxx@xx.xx
Phone+1(855)632-5297
Emailxx@xx.xx
Phone+1(855)632-5297
Emailxx@xx.xx
Phone+1(855)632-5297
Emailxx@xx.xx
Phone+1(855)632-5297
Emailxx@xx.xx
Phone+1(855)632-5297
Emailxx@xx.xx
Phone+1(855)632-5297
Emailxx@xx.xx
Phone+1(855)632-5297
Emailxx@xx.xx
Phone+1(855)632-5297
Emailxx@xx.xx
Phone+1(855)632-5297
Emailxx@xx.xx
Phone+1(855)632-5297
Emailxx@xx.xx
Phone+1(855)632-5297
Emailxx@xx.xx
Phone+1(855)632-5297
Emailxx@xx.xx
Phone+1(855)632-5297
Emailxx@xx.xx
Phone+1(855)632-5297
Emailxx@xx.xx
Phone+1(855)632-5297
Emailxx@xx.xx
Phone+1(855)632-5297
Emailxx@xx.xx
Phone+1(855)632-5297
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 HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100357599716875 [Primary]
GS130357599716876 [Package]
Contains: 00357599716875
Package: Case [4 Units]
In Commercial Distribution
NDC/NHRIC57599-0716-87 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MDSSensor, glucose, invasive

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 Date2016-10-20

On-Brand Devices [FreeStyle Libre Pro]

30357599716876FreeStyle Libre Pro Reader Kit
30357599715626FreeStyle Libre Pro Sensor Kit
30357599715619FreeStyle Libre Pro Sensor Kit
57599-0715-55FreeStyle Libre Pro Reader Kit
30357599000418FreeStyle Libre Pro Reader Kit US DOD
30093815751701FreeStyle Libre Pro Software

Trademark Results [FreeStyle Libre Pro]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FREESTYLE LIBRE PRO
FREESTYLE LIBRE PRO
86062997 5251425 Live/Registered
Abbott Diabetes Care Inc.
2013-09-12

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.