ABBOTT DIABETES CARE INC

Address:2701 Harbor Bay Parkway,Alameda,CA,94502,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Glucose dehydrogenase, glucose (LFR) (3) Integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems (QLG) (3) SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER (NBW) (3) Continuous glucose monitor retrospective data analysis software (PHV) (2) Continuous glucose monitor secondary display (PJT) (1) Medical device data system (OUG) (1)

Premarket Exempt

No Yes

Clear

FreeStyle Libre 3 App - 00357599817008 Catalog Number : 72077-01

Device Description : FreeStyle Libre 3 iOS App US

Device Class : 2

Duns Number: 966390890

Premarket Exempt : No

Product Code : QLG

Prescription Use : Yes

Device Count : 1

FreeStyle Libre 3 - 00357599818005 Catalog Number : 72081

Device Description : FreeStyle Libre 3 Sensor Kit US

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : QLG

Prescription Use : Yes

Device Count : 1

FreeStyle Libre 3 - 00357599819002 Catalog Number : 72080

Device Description : FreeStyle Libre 3 Sensor Kit NFRS

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : QLG

Prescription Use : Yes

Device Count : 1

LibreView - 00357599823009 Catalog Number : 72156-01

Device Description : LibreView

Device Class : 1

Duns Number: 966390890

Premarket Exempt : Yes

Product Code : PHV

Prescription Use : No

Device Count : 1

LibreLinkUp - 00357599824006 Catalog Number : 72154-01

Device Description : LibreLinkUp

Device Class : 2

Duns Number: 966390890

Premarket Exempt : Yes

Product Code : PJT

Prescription Use : No

Device Count : 1

LibreView Government - 00357599826000 Catalog Number : 72157-01

Device Description : LibreViewGov

Device Class : 1

Duns Number: 966390890

Premarket Exempt : Yes

Product Code : PHV

Prescription Use : No

Device Count : 1

FreeStyle Lite - 00699073000019 Catalog Number : 70804

Device Description : FreeStyle Lite Blood Glucose Monitoring System

Device Class : 2

Duns Number: 966390890

Premarket Exempt : No

Product Code : NBW, LFR

Prescription Use : No

Device Count : 1

FreeStyle Freedom Lite - 00699073000026 Catalog Number : 70920

Device Description : FreeStyle Freedom Lite Blood Glucose and Monitoring System

Device Class : 2

Duns Number: 966390890

Premarket Exempt : No

Product Code : LFR, NBW

Prescription Use : No

Device Count : 1

Abbott - 00699073000842 Catalog Number : 70851

Device Description : Abbott Diabetes Care USB Data Cable Software

Device Class :

Duns Number: 966390890

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : No

Device Count : 1

FreeStyle Freedom - 00699073110046 Catalog Number : 11004

Device Description : FreeStyle Freedom Blood Glucose Monitoring System

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : NBW, LFR

Prescription Use : No

Device Count : 1

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