SIMPLE DIAGNOSTICS INC

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

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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) (3) Lancet, Blood (FMK) (3) Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature (QRK) (2) System, Measurement, Blood-Pressure, Non-Invasive (DXN) (2) Multiple Use Blood Lancet For Single Patient Use Only (QRL) (1) Meter, Peak Flow, Spirometry (BZH) (1) Glucose Oxidase, Glucose (CGA) (1)

Premarket Exempt

No Yes

Clear

Clever Choice Peak Flow Meter - 00850002860382 Catalog Number : 50002-0860-38

Device Description : Clever Choice Peak Flow Meter 50-800 L/Min Adult and Child Mouthpieces included

Device Class :

Duns Number: 004135503

Premarket Exempt : No

Product Code : BZH

Prescription Use : No

Device Count : 1

Pharmacist Choice - 00850002860603 Catalog Number : 50002-0860-60

Device Description : Simple Diagnostics Blood Lancets

Device Class :

Duns Number: 004135503

Premarket Exempt : No

Product Code : FMK, QRK

Prescription Use : No

Device Count : 100

Simple Diagnostics - 00898302001005 Catalog Number : 98302-0001-00

Device Description : Simple Diagnostics Universal Lancing Device

Device Class : 2

Duns Number: 004135503

Premarket Exempt : No

Product Code : FMK, QRL

Prescription Use : No

Device Count : 1

Clever Choice - 00898302001036 Catalog Number : 98302-0001-03

Device Description : Control Solution to apply to Blood Glucose Test Strips to verify the accuracy of Control Solution to apply to Blood Glucose Test Strips to verify the accuracy of readings from a Blood Glucose meter and/or Test Strips.

Device Class :

Duns Number: 004135503

Premarket Exempt : No

Product Code : CGA

Prescription Use : No

Device Count : 1

Pharmacist Choice - 00898302001043 Catalog Number : 98302-0001-04

Device Description : Simple Diagnostics Lancets

Device Class : 2

Duns Number: 004135503

Premarket Exempt : No

Product Code : FMK, QRK

Prescription Use : No

Device Count : 1

Clever Choice - 00898302001203 Catalog Number : 98302-0001-20

Device Description : Blood Glucose Test Strips for Clever Choice HD and Voice HD Blood Glucose Meters.

Device Class :

Duns Number: 004135503

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 50

Clever Choice - 00898302001289 Catalog Number : 98302-0001-28

Device Description : Blood Glucose Test Strips for Clever Choice Pro and Mini Blood Glucose Meters.

Device Class :

Duns Number: 004135503

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 50

Clever Choice - 00898302001296 Catalog Number : 98302-0001-29

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

Device Class :

Duns Number: 004135503

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

Clever Choice - 00898302001357 Catalog Number : 98302-0148-12

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. Speaks to the user in English or Spanish

Device Class : 2

Duns Number: 004135503

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Clever Choice - 00898302001364 Catalog Number : 98302-0148-13

Device Class : 2

Duns Number: 004135503

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

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