TRIVIDIA HEALTH, INC.

Address:2400 NW 55TH CT,Fort Lauderdale,FL,33309,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

System, Test, Blood Glucose, Over The Counter (NBW) (6) Lancet, Blood (FMK) (4) Glucose Dehydrogenase, Glucose (LFR) (3) Glucose Oxidase, Glucose (CGA) (1) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (1)

Premarket Exempt

No Yes

Clear

TRUEplus - 00010939700445 Catalog Number : S1054LB28-100

Device Description : Sunmark TRUEplus Sterile Lancets

Device Class :

Duns Number: 151810868

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 100

TRUEplus - 00010939701442 Catalog Number : S1054DB30-100

Device Description : Sunmark TRUEplus Sterile Lancets

Device Class :

Duns Number: 151810868

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 100

TRUEplus - 00010939702449 Catalog Number : S1054MC33-100

Device Description : Sunmark TRUEplus Sterile Lancets

Device Class :

Duns Number: 151810868

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 100

TRUEdraw - 00010939709448 Catalog Number : S3054-01

Device Description : Sunmark TRUEdraw Lancing Device

Device Class : 2

Duns Number: 151810868

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 1

TRUE METRIX - 00010939719447 Catalog Number : RE4054-01

Device Description : sunmark TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER

Device Class :

Duns Number: 151810868

Premarket Exempt : No

Product Code : NBW, LFR

Prescription Use : Yes

Device Count : 1

TRUE METRIX - 00010939722447 Catalog Number : RE4054-00

Device Description : sunmark TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER - FREE METER ONLY

Device Class :

Duns Number: 151810868

Premarket Exempt : No

Product Code : NBW, LFR

Prescription Use : Yes

Device Count : 1

TRUE METRIX AIR - 00010939742445 Catalog Number : REA4054-01

Device Description : sunmark TRUE METRIX AIR SELF MONITORING BLOOD GLUCOSE METER

Device Class :

Duns Number: 151810868

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

TRUEtrack - 00010939755339 Catalog Number : A4054-81

Device Description : sunmark TRUEtrack BLOOD GLUCOSE MONITORING SYSTEM

Device Class : 1

Duns Number: 151810868

Premarket Exempt : No

Product Code : NBW, CGA, JJX

Prescription Use : No

Device Count : 1

TRUE METRIX GO - 00011822002783 Catalog Number : RF4066-01

Device Description : Rite Aid TRUE METRIX GO Self Monitoring Blood Glucose Meter

Device Class :

Duns Number: 151810868

Premarket Exempt : No

Product Code : NBW

Prescription Use : Yes

Device Count : 1

TRUE METRIX - 00011822445610 Catalog Number : RE4066-01

Device Description : RITE AID PHARMACY TRUE METRIX self monitoring blood glucose meter

Device Class :

Duns Number: 151810868

Premarket Exempt : No

Product Code : NBW, LFR

Prescription Use : Yes

Device Count : 1

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