FDA.reportPublic FDA data

FreeStyle InsuLinx

Primary DI
00699073712271
Brand
FreeStyle InsuLinx
Company
ABBOTT DIABETES CARE INC
Model
71227
Catalog number
71227
Device description
FreeStyle InsuLinx Blood Glucose Test Strips
Published
2016-07-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LFRGlucose dehydrogenase, glucose
NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFRGlucose Dehydrogenase, GlucoseClinical Chemistry2
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152328000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152328000FreeStyle InsuLinx Blood Glucose Monotioring SystemAbott Laboratories2015-09-17LFR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30699073712272PackageGS112In Commercial Distribution
00699073712271PrimaryGS10
99073-0712-27SecondaryNDC/NHRIC0
10699073712278Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3069907371227230699073712272
00699073712271006990737122716990737122710699073712271
1069907371227810699073712278

GMDN Terms#

Term, Definition table
TermDefinition
Multiple clinical chemistry analyte monitoring system IVD, home-useA collection of devices including a portable, electrically-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used together for the quantitative measurement of multiple clinical chemistry analytes in a clinical specimen. Analytes detected may include electrolytes, specific proteins, clinical chemistry substrates (e.g., lipid profile), liver and/or cardiac function test analytes, and/or enzymes. It is intended to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature40 Degrees Fahrenheit86 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(800)222-3100xx@xx.xx

Regulatory Flags#

DUNS number
966390890
Device count
100
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00357599844011FreeStyle Libre 3 Plus78768787682025-07-25
00357599850005Lingo78782-0178782-012025-11-17
00357599820015FreeStyle Libre 372079720792025-07-25
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00357599842017FreeStyle Libre 378754787542025-07-25
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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

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