FDA.reportPublic FDA data

FreeStyle LibreLink

Primary DI
00357599000059
Brand
FreeStyle LibreLink
Company
ABBOTT DIABETES CARE INC
Model
71733-01
Catalog number
71733-01
Device description
FreeStyle LibreLink iOS US
Published
2019-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
P160030010

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P160030010Freestyle Libre Flash Glucose Monitoring SystemAbbott Diabetes Care, Inc.2017-09-27PZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00357599000059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00357599000059003575990000593575990000590357599000059

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
966390890
Device count
1

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
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
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