LIFESCAN, INC.

Address:20 Valley Stream Parkway,Malvern,PA,19355,US

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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 Oxidase, Glucose (CGA) (1) System, Test, Blood Glucose, Over The Counter (NBW) (1)

Premarket Exempt

Clear

OneTouch Ultra Blue Test Strips - 00353885012652 Catalog Number : 024-273

Device Description : OneTouch Ultra Test Strips Blue for blood glucose testing with: OneTouch Ultra 2 OneTouch Ultra Test Strips Blue for blood glucose testing with: OneTouch Ultra 2, OneTouch UltraMini, OneTouch Ultra, OneTouch UltraSmart, OneTouch Ping and OneTouch UltraLink Meters

Device Class :

Duns Number: 153409313

Premarket Exempt : No

Product Code : NBW, CGA

Prescription Use : No

Device Count : 60

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