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

SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER (NBW) (5) Lancet, blood (FMK) (2) Glucose dehydrogenase, glucose (LFR) (2) Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated (PZE) (1) NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.) (JIN) (1) Continuous glucose monitor retrospective data analysis software (PHV) (1) Sensor, glucose, invasive (MDS) (1)

Premarket Exempt

Yes No

Clear

FreeStyle Libre - 00357599000240 Catalog Number : 71739

Device Description : FreeStyle Libre Reader Kit US DOD

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : PZE

Prescription Use : Yes

Device Count : 1

Precision Xceed Pro - 00357599000257 Catalog Number : 70907-05

Device Description : Precision Xceed Pro

Device Class : 1

Duns Number: 966390890

Premarket Exempt : No

Product Code : JIN, NBW, LFR

Prescription Use : No

Device Count : 1

FreeStyle Precision Neo - 00357599000301 Catalog Number : 71741

Device Description : FreeStyle Precision Neo Blood Glucose Monitoring System Not For Retail Sale

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : NBW, LFR

Prescription Use : No

Device Count : 1

FreeStyle Precision Neo - 00357599000332 Catalog Number : 71748

Device Description : FreeStyle Precision Neo Blood Glucose Test Strips Not For Retail Sale

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 10

FreeStyle Precision Neo - 00357599000349 Catalog Number : 71749

Device Description : FreeStyle Precision Neo Blood Glucose Test Strips

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 50

FreeStyle Precision Neo - 00357599000356 Catalog Number : 71750

Device Description : FreeStyle Precision Neo Blood Glucose Test Strips

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 100

FreeStyle Libre Pro - 00357599000417 Catalog Number : 71760

Device Description : FreeStyle Libre Pro Reader Kit US DOD

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : MDS

Prescription Use : Yes

Device Count : 1

FreeStyle Libre - 00357599000479 Catalog Number : 71527

Device Description : FreeSyle Libre Software CD

Device Class : 1

Duns Number: 966390890

Premarket Exempt : Yes

Product Code : PHV

Prescription Use : Yes

Device Count : 1

FreeStyle - 00357599000660 Catalog Number : 71582

Device Description : FreeStyle Lancing Device II

Device Class : 2

Duns Number: 966390890

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 1

Abbott - 00357599000691 Catalog Number : 70901

Device Description : Abbott SF Single Use Lancing Device

Device Class :

Duns Number: 966390890

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 200

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