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

System, Measurement, Blood-Pressure, Non-Invasive (DXN) (5) System, Test, Blood Glucose, Over The Counter (NBW) (2) Needle, Hypodermic, Single Lumen (FMI) (1) Pad, Heating, Powered (IRT) (1) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (1)

Premarket Exempt

No Yes

Clear

Advocate Arm BPM S/M CUFF - 00894046001400 Catalog Number : 406 S/M

Device Description : Advocate Blood Pressure Monitor Model SPBP-04, Upper Arm Small/Medium Cuff

Device Class :

Duns Number: 043081723

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Advocate Arm BPM L Cuff - 00894046001417 Catalog Number : 406L

Device Description : Advocate Blood Pressure Monitor Model SPBP-04, Upper Arm Large Cuff

Device Class :

Duns Number: 043081723

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

American Heart- Tech Non-Speaking Wrist BPM - 00894046001509 Catalog Number : 405-HT

Device Description : American Heart- Tech Blood Pressure Monitor Non-Speaking Wrist with Color Indicator

Device Class :

Duns Number: 043081723

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Advocate Blood Pressure Monitor, Wrist, Model SPBP-02, Bilingual - 00894046001516 Catalog Number : 403-FG

Device Description : Advocate Blood Pressure Monitor, Wrist, Model SPBP-02 Color Indicator, Bilingual

Device Class :

Duns Number: 043081723

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Advocate Pen Needle 29G 12.7MM - 00894046001523 Catalog Number : 600

Device Description : Advocate Pen Needle 29G 12.7MM sterile 100 Count

Device Class :

Duns Number: 043081723

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 1

Advocate Blood Pressure Monitor Model SPBP-04 Upper Arm XL Cuff - 00894046001530 Catalog Number : 406XL

Device Description : Advocate Blood Pressure Monitor Model SPBP-04 Upper Arm XL Cuff

Device Class :

Duns Number: 043081723

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

ADVOCATE HEATING PAD CLASSIC SIZE - 00894046001554 Catalog Number : JY6100

Device Description : HEATING PAD CLASSIC 12"x 15'' SIZE AUTO TURN OFF 4 HEAT SETTINGS HEATING PAD CLASSIC 12"x 15'' SIZE AUTO TURN OFF 4 HEAT SETTINGS

Device Class : 2

Duns Number: 043081723

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : No

Device Count : 1

Advocate Redi-Code+ Non Speaking Blood Glucose Meter - 00894046001561 Catalog Number : BMB-001A

Device Description : Advocate Redi-Code+ Non Speaking Blood Glucose Meter

Device Class :

Duns Number: 043081723

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

Advocate Redi- Code+ Test Strips for Blood Glucose 50 Count - 00894046001578 Catalog Number : BMB002

Device Description : Advocate Redi- Code+ Test Strips for accurate monitoring of blood glucose levels, 50 Count

Device Class :

Duns Number: 043081723

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 50

Advocate Control Solutions Low - 00894046001585 Catalog Number : BMB003

Device Description : Advocate Control Solutions Level 1 Low 4 ml Bottle

Device Class :

Duns Number: 043081723

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

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