INTUITY MEDICAL, INC.

Address:3500 W. WARREN AVE,Fremont,CA,94538,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

Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (2) System, Test, Blood Glucose, Over The Counter (NBW) (2)

Premarket Exempt

No Yes

Clear

POGO Automatic Blood Glucose Monitoring System - 00856176008001 Catalog Number : 00856176008001

Device Description : Blood Glucose Meter

Device Class :

Duns Number: 941150349

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

POGO Automatic Control Solution - 00856176008025 Catalog Number : 00856176008025

Device Description : Level 1 Control Solution (75 mg/dL)

Device Class : 1

Duns Number: 941150349

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : No

Device Count : 1

POGO Automatic Control Solution - 00856176008032 Catalog Number : 00856176008032

Device Description : Level 2 Control Solution (150 mg/dL)

Device Class : 1

Duns Number: 941150349

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : No

Device Count : 1

POGO Automatic Test Cartridges - 00856176008056 Catalog Number : 00856176008056

Device Description : Blood glucose test cartridges with 10 tests per cartridge. Five cartridges per t Blood glucose test cartridges with 10 tests per cartridge. Five cartridges per tube (50 tests)

Device Class :

Duns Number: 941150349

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 5

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