Resuscitator face mask, single-use - India CDSCO Medical Device Registration

Resuscitator face mask, single-use is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2022/000588_75ebaa14ce565ad9cc44c5f4517ff826_10f94e815ba553d920301834c2c19843. This device is marketed under the brand name AMKAY. The license holder is AMKAY PRODUCTS PRIVATE LIMITED, and it is classified as Device Class Class A. The approving authority is Kokan Division.

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CDSCO Registered

Class Class A

Resuscitator face mask, single-use

UID: MFG/MD/2022/000588_75ebaa14ce565ad9cc44c5f4517ff826_10f94e815ba553d920301834c2c19843

Brand Name

AMKAY

License Holder

AMKAY PRODUCTS PRIVATE LIMITED

Device Class

Class A

Approving Authority

Kokan Division

Product Information

A non-sterile, flexible, form-shaped device that is placed over a patient's nose and mouth to direct ambient air, or medical oxygen (AMKAY) and air, from a resuscitator to the upper airway and lungs. It is typically made of nonconductive sterilizable materials (AMKAY) that will create a gastight seal against the face. It will typically include a 15 mm and/or 22 mm connector and is available in a range of sizes (AMKAY). It will be directly attached to the resuscitator and held in place on the patient's face by the operator. This device is intended for use with a breathing resuscitator but may be used for the delivery of anaesthesia gases. This is a single-use device.

Class A

Steam Vaporiser

Brand: AMKAY

AMKAY PRODUCTS PRIVATE LIMITED

Class A

Brand: AMKAY

Class A