ABBOTT DIABETES CARE INC

Address:1360 SOUTH LOOP RD.,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

Sensor, glucose, invasive (MDS) (4) Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated (PZE) (4) Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated (PZE) (2)

Premarket Exempt

Yes No

Clear

FreeStyle Libre - 00357599000851 Catalog Number : 71942

Device Description : FS Libre Sensor Kit

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : PZE

Prescription Use : Yes

Device Count : 1

FreeStyle Libre 14 day - 00357599000974 Catalog Number : 71937

Device Description : FreeStyle Libre 14 day Reader Kit US

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : PZE

Prescription Use : Yes

Device Count : 1

FreeStyle Libre 14 day - 00357599000981 Catalog Number : 71936

Device Description : FreeStyle Libre 14 day Reader Kit US DOD

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : PZE

Prescription Use : Yes

Device Count : 1

FreeStyle Libre 14 day - 00357599001018 Catalog Number : 71940

Device Description : FreeStyle Libre 14 day Sensor Kit

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : PZE

Prescription Use : Yes

Device Count : 1

FreeStyle Libre 14 day - 00357599001025 Catalog Number : 71939

Device Description : FreeStyle Libre 14 day Sensor Kit NFRS

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : PZE

Prescription Use : Yes

Device Count : 1

FreeStyle Libre 14 day - 00357599002008 Catalog Number : 71938

Device Description : FreeStyle Libre 14 day Reader Kit US

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : PZE

Prescription Use : Yes

Device Count : 1

FreeStyle Libre Pro - 00357599715557 Catalog Number : 71555

Device Description : FreeStyle Libre Pro Reader Kit

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : MDS

Prescription Use : Yes

Device Count : 1

FreeStyle Libre Pro - 00357599715618 Catalog Number : 71561

Device Description : FreeStyle Libre Pro Sensor Kit

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : MDS

Prescription Use : Yes

Device Count : 1

FreeStyle Libre Pro - 00357599715625 Catalog Number : 71562

Device Description : FreeStyle Libre Pro Sensor Kit

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : MDS

Prescription Use : Yes

Device Count : 1

FreeStyle Libre Pro - 00357599716875 Catalog Number : 71687

Device Description : FreeStyle Libre Pro Reader Kit

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : MDS

Prescription Use : Yes

Device Count : 1

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