BIOVO TECHNOLOGIES LTD

Address:1 Haherut st.,Yavne,IL

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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

Cuff, Tracheal Tube, Inflatable (BSK) (2)

Premarket Exempt

Clear

Cuffix - 07290017345017 Catalog Number :

Device Description : The Cuffix is intended to measure and regulate, through passive control, intracu The Cuffix is intended to measure and regulate, through passive control, intracuff pressure of Endotracheal tubes, Tracheotomy tubes and Laryngeal Masks Airways (LMAs) (supraglottic airways). The device is intended for single patient use, under medical supervision in hospitals, pre-hospital (EMS), extended care facilities or outpatient clinics, where a patient may be intubated.

Device Class :

Duns Number: 600248533

Premarket Exempt : No

Product Code : BSK

Prescription Use : Yes

Device Count : 1

Cuffix - 07290017345031 Catalog Number :

Device Class : 2

Duns Number: 600248533

Premarket Exempt : No

Product Code : BSK

Prescription Use : Yes

Device Count : 1

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