Video Stylet - India CDSCO Medical Device Registration

Video Stylet is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000098_77870037fdacb955b9096969f5df3768_f380686a80e912034a2bdc145aa2d036. This device is marketed under the brand name ProVu. The license holder is Flexicare Medical ( INDIA ) Private Limited., and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Video Stylet

UID: IMP/MD/2019/000098_77870037fdacb955b9096969f5df3768_f380686a80e912034a2bdc145aa2d036

Brand Name

ProVu

License Holder

Flexicare Medical ( INDIA ) Private Limited.

Device Class

Class B

Approving Authority

CDSCO

Product Information

The ProVu Video Stylet (ProVu) is a sterile, single-use, video-enabled stylet and ETT intubation system with malleable and directional control intended to assist with oral and nasal intubations and designed for use in adults in a hospital environment. The device consists of a control wheel at the proximal end and an incorporated light source and video camera at the distal end. The ProVu VS is connected to a ProVu Display to provide a video stream from the distal end of the ETT. A malleable rod is pre-loaded to facilitate curvature of the ETT and can be removed to make the ETT more flexible. The ProVu VS is designed to assist placement of the ETT by providing video images of the patient’s airway anatomy during intubation. The directional ETT tip allows for controlled flexion and retroflexion enabling precise placement through the vocal cords and video confirmation of the correct ETT placement within the trachea

Class B

Split Lumen Breathing Systems

Brand: ProVu

Flexicare Medical ( INDIA ) Private Limited.

Class B

Brand: Flexicare

Class A