ASCENSIA DIABETES CARE US INC.

Address:100 Summit Lake Drive,Valhalla,NY,10595,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) (2) Lancet, Blood (FMK) (2) System, Test, Blood Glucose, Over The Counter (NBW) (2)

Premarket Exempt

No Yes

Clear

CONTOUR®NEXT and MICROLET® - 40301939781519 Catalog Number : 9781

Device Description : Mixed product shipper case containing 3 cartons of CONTOUR®NEXT Blood Glucose Te Mixed product shipper case containing 3 cartons of CONTOUR®NEXT Blood Glucose Test Strips (Package DI Number 00301937312212) and 300 MICROLET® lancets (provided sterile).

Device Class : 2

Duns Number: 080028910

Premarket Exempt : No

Product Code : FMK, LFR, NBW

Prescription Use : Yes

Device Count : 1

CONTOUR®NEXT and MICROLET® - 40301939782516 Catalog Number : 9782

Device Description : Mixed product shipper case containing 1 carton of CONTOUR®NEXT Blood Glucose Tes Mixed product shipper case containing 1 carton of CONTOUR®NEXT Blood Glucose Test Strips (Package DI Number 00301937312212) and 100 MICROLET® lancets (provided sterile).