DIABETIC SUPPLY OF SUNCOAST, INC.

Address:Plaza Nunez#3 Carr #2 30 Suite 2,Vega Alta,PR,00692,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

Needle, Hypodermic, Single Lumen (FMI) (4) Lancet, Blood (FMK) (2) Pad, Heating, Powered (IRT) (1) System, Measurement, Blood-Pressure, Non-Invasive (DXN) (1) System, Test, Blood Glucose, Over The Counter (NBW) (1) Thermometer, Electronic, Clinical (FLL) (1)

Premarket Exempt

No Yes

Clear

ADVOCATE Lancing Device Red Dot - 00852982006002 Catalog Number : 329

Device Description : Advocate Lancing Device Red Dot, ergonomically designed, safety switch feature l

Device Class :

Duns Number: 043081723

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 1

ADVOCATE Lancing Device Phoenix B - 00852982006040 Catalog Number : PHX-01

Device Description : Advocate Lancing Device Phoenix B, intended to be used for controlled skin punct

Device Class : 2

Duns Number: 043081723

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 1

Advocate Pen Needle 31G 6MM - 00852982006132 Catalog Number : 643

Device Description : Advocate Pen Needle 31G 6MM sterile 100 Count

Device Class :

Duns Number: 043081723

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 100

Advocate Pen Needle 32G 4MM - 00852982006149 Catalog Number : 644

Device Description : Advocate Pen Needle 32G 4MM sterile for Insulin 100 Count

Device Class :

Duns Number: 043081723

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 100

Advocate Pen Needle 33G 4MM 100 Count - 00852982006156 Catalog Number : 645

Device Description : Advocate Pen Needle 33G 4MM 5/32" 100 Count

Device Class :

Duns Number: 043081723

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 100

Advocate Pen Needle 29G 12MM 100 Count - 00852982006330 Catalog Number : 650

Device Description : Advocate Pen Needle 29G 12MM 100 Count

Device Class :

Duns Number: 043081723

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 100

ADVOCATE ORAL & RECTAL THERMOMETER - 00852982006354 Catalog Number : 145

Device Description : Advocate Thermometer, Oral/Rectal, flexible tip probe, beep alert with 8 second

Device Class : 2

Duns Number: 043081723

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Advocate Blood Pressure Monitor Non-Speaking Wrist - 00852982006408 Catalog Number : FT-B05W

Device Description : Advocate Blood Pressure Monitor Non-Speaking Wrist

Device Class :

Duns Number: 043081723

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

ADVOCATE Heating Pad International - 00852982006415 Catalog Number : JY6500

Device Description : ADVOCATE Heating Pad, International 30 CM X 40 CM, 220-240 V, Auto Turn Off, 4 H

Device Class : 2

Duns Number: 043081723

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : No

Device Count : 1

Advocate Redi-Code+ Test Strips for Blood Glucose 10 count - 00852982006491 Catalog Number : BMB002-10

Device Description : Advocate Redi-Code+ Test Strips for Blood Glucose 10 count

Device Class :

Duns Number: 043081723

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 10

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