SIMPLE DIAGNOSTICS INC

Address:5208 Grand Ave,Maspeth,NY,11378,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

Pad, Heating, Powered (IRT) (4) Needle, Hypodermic, Single Lumen (FMI) (2) Orthosis, Truncal/Orthosis, Limb (MRI) (1) Pad, Alcohol, Device Disinfectant (LKB) (1) System, Measurement, Blood-Pressure, Non-Invasive (DXN) (1) System, Test, Blood Glucose, Over The Counter (NBW) (1)

Premarket Exempt

No Yes

Clear

Clever Choice - 00898302001890 Catalog Number :

Device Description : Orthopedic Back Brace

Device Class : 1

Duns Number: 004135503

Premarket Exempt : Yes

Product Code : MRI

Prescription Use : No

Device Count : 1

Clever Choice - 00898302001906 Catalog Number : 98302-0001-90

Device Description : Clever Choice Comfort Heat

Device Class : 2

Duns Number: 004135503

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : No

Device Count : 1

Clever Choice - 00898302001913 Catalog Number : 98302-0001-91

Device Description : Clever Choice Comfort Heat + (plus)

Device Class : 2

Duns Number: 004135503

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : No

Device Count : 1

Clever Choice - 00898302001937 Catalog Number : 98302-0001-93

Device Description : Clever Choice Comfort Heat

Device Class : 2

Duns Number: 004135503

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : No

Device Count : 1

Clever Choice - 00898302001944 Catalog Number : 98302-0001-94

Device Description : Clever Choice Comfort Heat + (plus)

Device Class : 2

Duns Number: 004135503

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : No

Device Count : 1

Clever Choice - 00898302001951 Catalog Number : 98302-0001-30

Device Description : Automatic Blood Pressure Monitor. Arm testing site. Also measures heart rate. Di Automatic Blood Pressure Monitor. Arm testing site. Also measures heart rate. Displays Blood Pressure reading as well as a World Health Organization rating of Blood Pressure readings, to easily indicate to user whether their blood pressure is too high or too low, and gives the user an idea of by how much.

Device Class :

Duns Number: 004135503

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Pharmacist Choice - 00898302001975 Catalog Number : 62379-005-06

Device Description : Pack of 100 70% Isopropyl Alcohol Prep Pads.

Device Class :

Duns Number: 004135503

Premarket Exempt : Yes

Product Code : LKB

Prescription Use : No

Device Count : 100

Clever Choice Comfort EZ - 00898302001982 Catalog Number : 98302-0001-98

Device Description : Insulin Pen Needle 5/16 inch length and 31 gauge

Device Class :

Duns Number: 004135503

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 100

Clever Choice Comfort EZ - 00898302001999 Catalog Number : 98302-0001-99

Device Description : Insulin Pen Needle 31G and 3/16 inch (5 mm) length

Device Class :

Duns Number: 004135503

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 100

Clever Choice - 00898302014081 Catalog Number : 98302-0001-07

Device Description : Clever Choice HD Blood Glucose meter. Uses HD Test Strips. Ideal for Diabetics

Device Class : 2

Duns Number: 004135503

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

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