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/2018/000148_bba53d2e7c87bebe4f41b08ae970c5ea_82de267fc9f77dc24691632313edeb59. This device is marketed under the brand name Shiley. The license holder is India Medtronic Private Limited ,Shed No. 3, Block No. 1, Survey No. 389, 400/2A & 2C, Pudur Main Road, Kuthambakkam - 600124, Poonamallee Taluk, Tiruvallur District ,Tiruvallur Tamil Nadu ,600124 ,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/2018/000148_bba53d2e7c87bebe4f41b08ae970c5ea_82de267fc9f77dc24691632313edeb59

Brand Name

Shiley

License Holder

India Medtronic Private Limited ,Shed No. 3, Block No. 1, Survey No. 389, 400/2A & 2C, Pudur Main Road, Kuthambakkam - 600124, Poonamallee Taluk, Tiruvallur District ,Tiruvallur Tamil Nadu ,600124 ,India

Device Class

Class B

Approving Authority

CDSCO

Product Information

The endobronchial tube is intended for use in thoracic surgery, bronchospirometry, for the administration of endobronchial anaesthesia and other uses commonly associated with endobronchial tubes. The tube allows isolation and selective inflation or deflation of either lung. The Endobronchial Tube Left (Shiley) is indicated for intubation of the left main bronchus while the Endobronchial Tube Right is indicated for right main bronchus intubation. The Right Angle Swivel Airway Connector caps allow introduction of suctioning and fibreoptic bronchoscopy instrument into the patient’s airway through the choice of a large port or a 12 French membrane port

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