FreeStyle Libre 14 day 71938-01

GUDID 30357599002009

FreeStyle Libre 14 day Reader Kit US

ABBOTT DIABETES CARE INC

Percutaneous glucose monitoring system
Primary Device ID30357599002009
NIH Device Record Key332a92e9-77b6-40ad-907d-cc9a7198b49b
Commercial Distribution StatusIn Commercial Distribution
Brand NameFreeStyle Libre 14 day
Version Model Number71938-01
Catalog Number71938-01
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 Usetrue
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)632-8658
Emailxx@xx.xx
Phone+1(855)632-8658
Emailxx@xx.xx

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70000 KiloPascal and 106000 KiloPascal
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
GS130357599002009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PZESensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-11-19
Device Publish Date2018-10-19

On-Brand Devices [FreeStyle Libre 14 day]

30357599001026FreeStyle Libre 14 day Sensor Kit NFRS
30357599001019FreeStyle Libre 14 day Sensor Kit
30357599002009FreeStyle Libre 14 day Reader Kit US
30357599000975FreeStyle Libre 14 day Reader Kit US, NFRS
30357599000982FreeStyle Libre 14 day Reader Kit US DOD
57599-0002-00FreeStyle Libre 14 day Reader Kit US
57599-0000-97FreeStyle Libre 14 day Reader Kit US

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