Resuscitator face mask, single-use
- UID
- MFG/MD/2022/000588_75ebaa14ce565ad9cc44c5f4517ff826_10f94e815ba553d920301834c2c19843
- Device class
- Class A
- Brand name
- AMKAY
- License holder
- AMKAY PRODUCTS PRIVATE LIMITED
- 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.
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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