FDA.reportPublic FDA data

FreeStyle Libre 14 day

Primary DI
30357599001026
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
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P160030017

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P160030017Freestyle Libre Flash Glucose Monitoring SystemAbbott Diabetes Care, Inc.2017-09-27PZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30357599001026PackageGS124In 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 glucose monitoring systemAn assembly of portable, battery-powered devices intended to continuously monitor interstitial-fluid glucose concentrations in a patient with diabetes mellitus, using an invasive technique. It consists of a sterile, electrochemical, percutaneously-inserted electrode that 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 or clinical setting, 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 Atmospheric Pressure70000 KiloPascal106000 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature39 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
966390890
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
00357599001025FreeStyle Libre 14 day71939719392018-10-10
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

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
00357599001025FreeStyle Libre 14 dayABBOTT DIABETES CARE INCPZE2018-10-10
30357599001019FreeStyle 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