NAVAJO MANUFACTURING COMPANY

Address:601 W 50TH AVE,Denver,CO,80216,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) (2) System, test, blood glucose, over the counter (NBW) (2) Single (specified) analyte controls (assayed and unassayed) (JJX) (1)

Premarket Exempt

Clear

On Call Express Blood Glucose Monitor - 00024291121824 Catalog Number :

Device Description : Blood Glucose Meter

Device Class :

Duns Number: 136941411

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

On Call Express Blood Glucose Monitoring System - 00024291121831 Catalog Number :

Device Description : Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G)

Device Class :

Duns Number: 136941411

Premarket Exempt : No

Product Code : NBW, CGA, JJX

Prescription Use : No

Device Count : 1

On Call Express Blood Glucose Test Strips - 00024291121848 Catalog Number :

Device Description : Blood Glucose Test Strips, box of 50 strips

Device Class :

Duns Number: 136941411

Premarket Exempt : No

Product Code : CGA

Prescription Use : No

Device Count : 50

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