PULMONE ADVANCED MEDICAL DEVICES LTD

Address:14 HaMelacha Street,Raananna Central,IL

Want to know more about this Organization? Request more information now!

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

Calculator, Pulmonary Function Data (BZC) (2) Spirometer, Diagnostic (BZG) (2)

Premarket Exempt

Clear

MiniBox - 07290016675009 Catalog Number : PUO-MiniBox

Device Description : The MiniBox is intended to measure lung function in adult and pediatric patients The MiniBox is intended to measure lung function in adult and pediatric patients while at rest (including spirometry and lung volumes ). The MiniBox is to be used by either a physician, respiratory therapist, or technician. A cleared single-use, disposable viral-bacterial filter separates the patient from the internal components of the device.The MiniBox measures all common spirometric measurements as well as relative and absolute lung volumes.

Device Class : 2

Duns Number: 514812275

Premarket Exempt : No

Product Code : BZC, BZG

Prescription Use : Yes

Device Count : 1

MiniBox+ - 07290016675016 Catalog Number :

Device Description : The PulmOne MiniBox+ is intended to measure lung function in adult and pediatric The PulmOne MiniBox+ is intended to measure lung function in adult and pediatric patients, 5 years and older, while at rest (including spirometry, lung volumes and diffusing capacity). The PulmOne MiniBox+ is to be used by a physician, respiratory therapist, or technician in a hospital or clinic setting

Device Class : 2

Duns Number: 514812275

Premarket Exempt : No

Product Code : BZG, BZC

Prescription Use : Yes

Device Count : 1

Previous 1 Next