Endobronchial tubes - India CDSCO Medical Device Registration

Endobronchial tubes is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000088_bba53d2e7c87bebe4f41b08ae970c5ea_56e5fd093fbeef8f95a01f43a1b955f2. This device is marketed under the brand name Portex. The license holder is Smiths Medical India Private Limited ,Gala 7A & 8A, Ground Floor, Building No. E-3, H No 508, Shree Rajalaxmi Logistics Park, Bhiwandi Nashik Road, Dhamangaon Bhiwandi, Thane - 421302, Maharashtra, India. ,Thane Maharashtra ,421302 ,India, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Endobronchial tubes

UID: IMP/MD/2020/000088_bba53d2e7c87bebe4f41b08ae970c5ea_56e5fd093fbeef8f95a01f43a1b955f2

Brand Name

Portex

License Holder

Smiths Medical India Private Limited ,Gala 7A & 8A, Ground Floor, Building No. E-3, H No 508, Shree Rajalaxmi Logistics Park, Bhiwandi Nashik Road, Dhamangaon Bhiwandi, Thane - 421302, Maharashtra, India. ,Thane Maharashtra ,421302 ,India

Device Class

Class B

Approving Authority

CDSCO

Product Information

It is intended for use in thoracic surgery, broncho-spirometry, for the administration of Endobronchial intubation. Endobronchial tubes are indicated for main stem bronchus intubation and allow for selective inflation and/or deflation, suctioning, independent lung ventilation and bronchoscopic viewing of either lung. Endobronchial tubes should always be used in accordance with currently accepted medical techniques. Swivel adapters are indicated where it is desirable to decrease the transmission of undesirable torque and motion between circuits and tracheal or tracheostomy tubes. The dual-axis swivel adapter can be used for suction access

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SMITHS MEDICAL INDIA PRIVATE LIMITED ,GALA 4B,5B,6B,7, 8, 9 & 10, GR FL, BLDG E-3, SHREE KALKI LOG SHREE RAJLAXMI LOGISTICS PARK, OLD BHIWANDI-AGRA ROAD, DHAMANGAON - 421302, Taluka BHIWANDI - 16, District THANE Z5 ,Thane Maharashtra ,421302 ,India

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