COMMONPATH LLC

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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, Measurement, Blood-Pressure, Non-Invasive (DXN) (6) Analyzer, Body Composition (MNW) (2) Thermometer, Electronic, Clinical (FLL) (2)

Premarket Exempt

No Yes

Clear

Ozeri - 00815817012326 Catalog Number :

Device Description : Default unit is LB. Batteries included. Utilizes 4 high precision GX sensors to Default unit is LB. Batteries included. Utilizes 4 high precision GX sensors to weigh up to 440 pounds (200 kilograms) in 0.2 lbs or 0.1 kg increments with Step On technology.Elegant reflective surface is made of high quality impact-resistant tempered glass, which is 4 times stronger than normal glass. Color- Black.This scale is not for clinical or diagnostic use.

Device Class :

Duns Number: 963223677

Premarket Exempt : Yes

Product Code : MNW

Prescription Use : No

Device Count : 1

Ozeri - 00815817012333 Catalog Number :

Device Description : Bathroom scale body fat analyzer. Support up to 8 users.Scale supports TARE func Bathroom scale body fat analyzer. Support up to 8 users.Scale supports TARE function.Default unit is LB. Units - kg/lb/st.Batteries included. Utilizes 4 high precision GX sensors to weigh up to 440 pounds (200 kilograms) in 0.2 lbs or 0.1 kg increments with Step On technology.Elegant reflective surface is made of high quality impact-resistant tempered glass, which is 4 times stronger than normal glass. Color- White.This scale is not for clinical or diagnostic use.

Device Class :

Duns Number: 963223677

Premarket Exempt : Yes

Product Code : MNW

Prescription Use : No

Device Count : 1

Ozeri - 00815817012456 Catalog Number :

Device Description : BP8H Blood pressure monitor with ARM CUFF

Device Class : 2

Duns Number: 963223677

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Ozeri - 00815817012685 Catalog Number : BP6T

Device Description : Ozeri Cardio Tech, Travel series. LEss than 1" inch(2.5cm) thick and 3.5 oz(100g Ozeri Cardio Tech, Travel series. LEss than 1" inch(2.5cm) thick and 3.5 oz(100g). New MWI(Measure white inflate) technology. 399 x 3 users.

Device Class : 2

Duns Number: 963223677

Premarket Exempt : Yes

Product Code : DXN

Prescription Use : No

Device Count : 1

Ozeri - 00815817012746 Catalog Number :

Device Description : BP3T Blood pressure monitor with ARM CUFFAdvanced one-step operation. Push-Butto BP3T Blood pressure monitor with ARM CUFFAdvanced one-step operation. Push-Button access to average blood pressure calculation. 4 AAA batteries and medium sized arm cuff.

Device Class : 2

Duns Number: 963223677

Premarket Exempt : Yes

Product Code : DXN

Prescription Use : No

Device Count : 1

Ozeri - 00815817013255 Catalog Number :

Device Class : 2

Duns Number: 963223677

Premarket Exempt : Yes

Product Code : DXN

Prescription Use : No

Device Count : 1

Ozeri - 00815817013293 Catalog Number : BP9W

Device Class :

Duns Number: 963223677

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Ozeri - 00815817013309 Catalog Number :

Device Description : Travel series BPM. LEss than 1" inch(2.5cm) thick and 3.5 oz(100g). New MWI(Meas Travel series BPM. LEss than 1" inch(2.5cm) thick and 3.5 oz(100g). New MWI(Measure white inflate) technology. 399 x 3 users.

Device Class :

Duns Number: 963223677

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Ozeri - 00815817013484 Catalog Number : NT1

Device Description : The Thermometer can display the result in either Fahrenheit or degree Celsius. The Thermometer can display the result in either Fahrenheit or degree Celsius. How to use:Steady and smoothly scroll the wheel either back and fourth or in one direction, so as to travel 12 inches or 30 cm. The scrolling will kinetically charge the device. Continue scroll the wheel until the LCD ON.Position the thermometer at the distance of less than 1 inch for the center of the patients eyebrows.Press and release the measure button.

Device Class :

Duns Number: 963223677

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Ozeri - 00815817014153 Catalog Number :

Device Description : The Thermometer can display the result in either Fahrenheit or degree Celsius. The Thermometer can display the result in either Fahrenheit or degree Celsius. Colour - BlackHow to use:Steady and smoothly scroll the wheel either back and fourth or in one direction, so as to travel 12 inches or 30 cm. The scrolling will kinetically charge the device. Continue scroll the wheel until the LCD ON.Position the thermometer at the distance of less than 1 inch for the center of the patients eyebrows.Press and release the measure button.

Device Class :

Duns Number: 963223677

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

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