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, non-adjunctive, factory-calibrated, user-initiated (PZE) (6) SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER (NBW) (4) Glucose dehydrogenase, glucose (LFR) (3) NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.) (JIN) (3)

Premarket Exempt

No Yes

Clear

FreeStyle LibreLink - 00357599000042 Catalog Number : 71732-01

Device Description : FreeStyle LibreLink Android US

Device Class : 3

Duns Number: 966390890

Premarket Exempt : No

Product Code : PZE

Prescription Use : Yes

Device Count : 1

FreeStyle LibreLink - 00357599000059 Catalog Number : 71733-01

Device Description : FreeStyle LibreLink iOS US

Device Class : 3

Duns Number: 966390890

Premarket Exempt : No

Product Code : PZE

Prescription Use : Yes

Device Count : 1

Precision Xceed Pro - 00357599000134 Catalog Number : 70900-05

Device Description : Precision Xceed Pro Blood Glucose and ß-Ketone Monitoring System

Device Class : 1

Duns Number: 966390890

Premarket Exempt : No

Product Code : LFR, JIN, NBW

Prescription Use : No

Device Count : 1

Precision Xceed Pro - 00357599000158 Catalog Number : 70900-04

Device Description : Precision Xceed Pro Blood Glucose and ß-Ketone Monitoring System

Device Class : 1

Duns Number: 966390890

Premarket Exempt : No

Product Code : NBW, LFR, JIN

Prescription Use : No

Device Count : 1

FreeStyle CoPilot - 00357599000172 Catalog Number : 71137

Device Description : FreeStyle CoPilot Health Management System

Device Class : 2

Duns Number: 966390890

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

Precision Xceed Pro - 00357599000189 Catalog Number : 70907-03

Device Description : Precision Xceed Pro Blood Glucose and ß-Ketone Monitoring System

Device Class : 1

Duns Number: 966390890

Premarket Exempt : No

Product Code : LFR, NBW, JIN

Prescription Use : No

Device Count : 1

FreeStyle Libre - 00357599000196 Catalog Number : 71536

Device Description : FreeStyle Libre Sensor Kit

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : PZE

Prescription Use : Yes

Device Count : 1

FreeStyle Libre - 00357599000202 Catalog Number : 71702

Device Description : FreeStyle Libre Sensor Kit

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : PZE

Prescription Use : Yes

Device Count : 1

FreeStyle Libre - 00357599000219 Catalog Number : 71525

Device Description : FreeStyle Libre Reader Kit US

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : PZE

Prescription Use : Yes

Device Count : 1

FreeStyle Libre - 00357599000226 Catalog Number : 71701

Device Description : FreeStyle Libre Reader Kit US

Device Class :

Duns Number: 966390890

Premarket Exempt : No

Product Code : PZE

Prescription Use : Yes

Device Count : 1

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