FDA.reportPublic FDA data

FreeStyle Libre Pro

Primary DI
00357599715618
Brand
FreeStyle Libre Pro
Company
ABBOTT DIABETES CARE INC
Model
71561
Catalog number
71561
Device description
FreeStyle Libre Pro Sensor Kit
Published
2017-01-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDSSensor, glucose, invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDSSensor, Glucose, InvasiveUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30357599715619PackageGS124In Commercial Distribution
00357599715618PrimaryGS10
57599-0715-61SecondaryNDC/NHRIC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3035759971561930357599715619
00357599715618003575997156183575997156180357599715618

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 Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature39 Degrees Fahrenheit77 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(855)632-5297xx@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
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
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20763000578798Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.MDS2022-01-02
20763000516233Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.MDS2021-06-03
00763000516239Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.MDS2021-06-03
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00763000455651Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.MDS2021-04-04
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00763000423124Paradigm® REAL-TimeMEDTRONIC MINIMED, INC.MDS2020-11-15
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00763000381103Guardian™ Connect AppMEDTRONIC MINIMED, INC.MDS2020-08-02
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00763000341923One-press SerterMEDTRONIC MINIMED, INC.MDS2020-05-16
00763000285852Guardian™ ConnectMEDTRONIC MINIMED, INC.MDS2019-08-29
00763000179601Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.MDS2019-06-23
00763000179625Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.MDS2019-06-22
20763000179629Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.MDS2019-06-22