Question 1

What types of medical devices does Commonpath LLC manufacture?

Accepted Answer

Commonpath LLC manufactures automatic-inflation electronic sphygmomanometers that are portable and designed for use on the finger, arm, or wrist, as well as bioelectrical body composition analysers and infrared patient thermometers intended for ear use. These product types are explicitly listed in the device data as the categories the company produces.

Question 2

Where is Commonpath LLC based?

Accepted Answer

Commonpath LLC is based in the United States, as stated in the country field of the device data and confirmed in the summary section which notes the company's location.

Question 3

Which regulatory registry lists Commonpath LLC's devices?

Accepted Answer

Commonpath LLC's devices are listed in the FDA's Unique Device Identification (FDA UDI) system, as indicated in the 'LISTED IN' field of the device data and reiterated in the summary which confirms the devices are listed in the FDA UDI system.

Question 4

How are Commonpath LLC's devices classified under regulatory frameworks?

Accepted Answer

Commonpath LLC's devices are classified as Class II medical devices, as specified in the 'DEVICE CLASSES' field of the device data and confirmed in the summary which states the devices are classified as Class II.

Device	Model / Reference	Registries	Class	Status
Ozeri	BP8H	FDA UDI	Class II	Active
Ozeri	BP6T	FDA UDI	Class II	Active
Ozeri	BP3T	FDA UDI	Class II	Active
Ozeri	ZB13	FDA UDI	Class II	Active
Ozeri	BP9W	FDA UDI	Class II	Active
Ozeri	TH1-W	FDA UDI	Class II	Active
Ozeri	BP6T	FDA UDI	Class II	Active
Ozeri	TH1-BL	FDA UDI	Class II	Active
Ozeri	ZB13-W	FDA UDI	Class II	Active
Ozeri	BP3T	FDA UDI	Class II	Active

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