ASCENSIA DIABETES CARE US INC.

Address:100 Summit Lake Drive,Valhalla,NY,10595,US

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Device Description : Wireless Blood Glucose Monitoring System. 1 kit. This kit contains the followin Wireless Blood Glucose Monitoring System. 1 kit. This kit contains the following items: CONTOUR® NEXT LINK Blood Glucose Meter; 25 CONTOUR® NEXT Blood Glucose Test Strips; CONTOUR® NEXT Level 2 Control Solution; MICROLET® 2 Lancing Device; Alternative Site Endcap; Adjustable Endcap; 25 Lancets (provided sterile); Quick Reference Guide; Wall Charger; User Guide; USB Extension Cable; Logbook; Carrying Case.

Device Class : 1

Duns Number: 080028910

Premarket Exempt : No

Product Code : JJX, LFR, NBW

Prescription Use : Yes

Device Count : 1

- Catalog Number : 90002904

Device Description : "Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and mana "Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose.Kit contains: CONTOUR® NEXT GEN blood glucose meter, Lancing Device, 10 CONTOUR® NEXT blood glucose test strips, 10 MICROLET® lancets, User Guide, Quick Reference Guide, Carrying Case, Web Registration/Warranty Card, CONTOUR® NEXT control solution"

Device Class :

Duns Number: 080028910

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

- Catalog Number : 9697

Device Description : Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and manag Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of diabetes.This kit contains the following items: CONTOUR® Next Blood Glucose Meter; 10 CONTOUR® NEXT Blood Glucose Test Strips; User Guide; Quick Reference Guide; Lancing Device; 10 Colored Lancets (provided sterile); Logbook; Carrying Case; CONTOUR® NEXT Control Solution; Warranty Card.

Device Class :

Duns Number: 080028910

Premarket Exempt : No

Product Code : JJX, LFR, NBW

Prescription Use : Yes

Device Count : 1

Device Description : Wireless Blood Glucose Monitoring System. 1 kit. This kit contains the followin Wireless Blood Glucose Monitoring System. 1 kit. This kit contains the following items: CONTOUR® NEXT LINK Blood Glucose Meter; 25 CONTOUR® NEXT Blood Glucose Test Strips; CONTOUR® NEXT Level 2 Control Solution; MICROLET® 2 Lancing Device; Alternative Site Endcap; Adjustable Endcap; 25 Lancets (provided sterile); Quick Reference Guide; Wall Charger; User Guide; USB Extension Cable; Logbook; Carrying Case.

Device Class : 1

Duns Number: 080028910

Premarket Exempt : No

Product Code : JJX, LFR, NBW

Prescription Use : Yes

Device Count : 1

Device Description : Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and manag Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose.Kit contains: CONTOUR® NEXT ONE Meter; 10 CONTOUR® NEXT Blood Glucose Test Strips; Lancing Device; 10 MICROLET® Colored Lancets (provided sterile); User Guide (including CONTOUR DIABETES app download instructions); Quick Reference Guide; Carrying Case; Web Registration / Warranty Card; CONTOUR® NEXT Control Solution.

Device Class :

Duns Number: 080028910

Premarket Exempt : No

Product Code : LFR, NBW

Prescription Use : No

Device Count : 1

Device Description : Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and manag Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose.Kit contains: CONTOUR® NEXT ONE Meter; Lancing Device; 10 MICROLET® Colored Lancets (provided sterile); User Guide (including CONTOUR DIABETES app download instructions); Quick Reference Guide; Carrying Case; Web Registration / Warranty Card; CONTOUR® NEXT Control Solution.

Device Class : 2

Duns Number: 080028910

Premarket Exempt : No

Product Code : LFR, NBW

Prescription Use : No

Device Count : 1

Device Description : Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and manag Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose.Kit contains: CONTOUR® NEXT ONE blood glucose meter; 10 CONTOUR® NEXT blood glucose test strips; Lancing Device; 10 Colored MICROLET® lancets (provided sterile); User Guide (including CONTOUR® DIABETES app download instructions); Quick Reference Guide; Carrying Case; Web Registration / Warranty Card; CONTOUR® NEXT control solution. A clear endcap is available for Alternative Site Testing (AST). It may not be included in your meter kit. If you perform AST and need a clear endcap (for palm), contact Diabetes Care Customer Service.

Device Class :

Duns Number: 080028910

Premarket Exempt : No

Product Code : LFR, NBW

Prescription Use : No

Device Count : 1

- Catalog Number : 1489A

Device Description : Control Solution - Normal, 1 x 2.5 mL

Device Class :

Duns Number: 080028910

Premarket Exempt : No

Product Code : JJX, NBW

Prescription Use : No

Device Count : 1

- Catalog Number : 1490A

Device Description : Control Solution - Low, 1 x 2.5 mL

Device Class :

Duns Number: 080028910

Premarket Exempt : No

Product Code : JJX, NBW

Prescription Use : No

Device Count : 1

- Catalog Number : 1491A

Device Description : Control Solution - High, 1 x 2.5 mL

Device Class :

Duns Number: 080028910

Premarket Exempt : No

Product Code : JJX, NBW

Prescription Use : No

Device Count : 1