FDA.reportPublic FDA data

FreeStyle Libre 14 day

Primary DI
00357599001025
Brand
FreeStyle Libre 14 day
Company
ABBOTT DIABETES CARE INC
Model
71939
Catalog number
71939
Device description
FreeStyle Libre 14 day Sensor Kit NFRS
Published
2018-10-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PZESensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PZESensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-InitiatedUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30357599001026PackageGS124Not in Commercial Distribution
00357599001025PrimaryGS10
57599-0001-02SecondaryNDC/NHRIC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3035759900102630357599001026
00357599001025003575990010253575990010250357599001025

GMDN Terms#

Term, Definition table
TermDefinition
Percutaneous interstitial fluid glucose monitoring system, electrochemicalAn assembly of electrically-powered, portable devices intended to continuously monitor interstitial fluid glucose concentrations in a patient with diabetes mellitus, using an invasive electrochemical technique. It consists of an electrochemical, percutaneously-inserted electrode that physically connects to a cable or transmitter which communicates with a monitor or receiver (not included) that captures, stores, and converts the sensor signals to glucose concentrations for display. The system may be used in the home and clinical settings, and aids in the detection of episodes of hyperglycaemia and hypoglycaemia, facilitating acute/long-term therapy adjustments.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature39 Degrees Fahrenheit77 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(855)632-8658xx@xx.xx

Regulatory Flags#

DUNS number
966390890
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00357599835019FreeStyle Libre 2 Plus78747787472025-07-25
00357599836016FreeStyle Libre 2 Plus78749787492025-07-25
00357599880002Instinct78893788932025-09-22
00357599843014FreeStyle Libre 3 Plus78769787692025-07-25
00357599844011FreeStyle Libre 3 Plus78768787682025-07-25
00357599850005Lingo78782-0178782-012025-11-17
00357599820015FreeStyle Libre 372079720792025-07-25
00357599821012FreeStyle Libre 372078720782025-06-25
00357599842017FreeStyle Libre 378754787542025-07-25
00357599833008Abbott78632786322023-01-20
30357599880003Instinct78893788932025-09-22
00357599803018FreeStyle Libre 271953719532025-07-25
00357599805012FreeStyle Libre 271951719512025-07-25
00357599804015FreeStyle Libre 271952719522025-07-25
30357599805013FreeStyle Libre 271951719512025-07-25
30357599820016FreeStyle Libre 372079720792025-07-25
30357599835010FreeStyle Libre 2 Plus78747787472025-07-25
30357599836017FreeStyle Libre 2 Plus78749787492025-07-25
30357599842018FreeStyle Libre 378754787542025-07-25
30357599803019FreeStyle Libre 271953-0171953-012025-07-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00357599000042FreeStyle LibreLinkABBOTT DIABETES CARE INCPZE2019-09-20
00357599000059FreeStyle LibreLinkABBOTT DIABETES CARE INCPZE2019-09-20
00357599000974FreeStyle Libre 14 dayABBOTT DIABETES CARE INCPZE2019-08-14
00357599002008FreeStyle Libre 14 dayABBOTT DIABETES CARE INCPZE2019-08-14
57599-0000-97FreeStyle Libre 14 dayABBOTT DIABETES CARE INCPZE2019-08-14
57599-0002-00FreeStyle Libre 14 dayABBOTT DIABETES CARE INCPZE2019-08-14
00357599000981FreeStyle Libre 14 dayABBOTT DIABETES CARE INCPZE2019-04-15
30357599000982FreeStyle Libre 14 dayABBOTT DIABETES CARE INCPZE2019-04-15
30357599000975FreeStyle Libre 14 dayABBOTT DIABETES CARE INCPZE2018-10-19
30357599002009FreeStyle Libre 14 dayABBOTT DIABETES CARE INCPZE2018-10-19
00357599001018FreeStyle Libre 14 dayABBOTT DIABETES CARE INCPZE2018-10-10
30357599001019FreeStyle Libre 14 dayABBOTT DIABETES CARE INCPZE2018-10-10
30357599001026FreeStyle Libre 14 dayABBOTT DIABETES CARE INCPZE2018-10-10
00357599000240FreeStyle LibreABBOTT DIABETES CARE INCPZE2018-08-15
30357599000241FreeStyle LibreABBOTT DIABETES CARE INCPZE2018-08-15
00357599000851FreeStyle LibreABBOTT DIABETES CARE INCPZE2018-06-01
30357599000852FreeStyle LibreABBOTT DIABETES CARE INCPZE2018-06-01
00357599000196FreeStyle LibreABBOTT DIABETES CARE INCPZE2017-11-20
00357599000202FreeStyle LibreABBOTT DIABETES CARE INCPZE2017-11-20
00357599000219FreeStyle LibreABBOTT DIABETES CARE INCPZE2017-11-20
00357599000226FreeStyle LibreABBOTT DIABETES CARE INCPZE2017-11-20
30357599000197FreeStyle LibreABBOTT DIABETES CARE INCPZE2017-11-20
30357599000203FreeStyle LibreABBOTT DIABETES CARE INCPZE2017-11-20
30357599000210FreeStyle LibreABBOTT DIABETES CARE INCPZE2017-11-20
30357599000227FreeStyle LibreABBOTT DIABETES CARE INCPZE2017-11-20