Catalogue values for BiPAP Full Face Mask (V2)
| Category | Specification | Bid Requirement (Allowed Values) |
|---|---|---|
| GENERAL FEATURES | Product Description | BiPAP Full Face Mask |
| Patient category | Adult | |
| Usage | Single-Use | |
| Sterility | Sterile | |
| Autoclavable | No | |
| PRODUCT INFORMATIONS | Non-toxic, Medical grade material | Yes |
| Material of Mask | 100% PVC, 100% Silicon | |
| Size | Large | |
| Auto adjustable mask | Yes | |
| Soft, smooth and transparent frame | Yes | |
| Flexible, winged forehead frame | Yes | |
| Light weight, strong, durable and flexible frame to stabilize the mask on the face | Yes | |
| Angular forehead support | Yes | |
| Headgear clips for easy to grip for attaching or detaching | Yes | |
| Squeeze type elbow for easy attachment and detachment from frame | Yes | |
| Single layer cushion, infection control | Yes | |
| Cushion locking system | Built-in | |
| Built-in Vent port for dispersing the air gently and quietly | Yes | |
| Air entrainment valve to allow breathing of room air when ventilator air pressure drops | Yes | |
| Universal Nebulizer port | Yes | |
| Expiratory port | Yes | |
| Bronchoscopy port | Yes | |
| Luer lock port caps | Yes | |
| Swivel assembly for easy connectivity | Yes | |
| PACKAGING | Type of Packing | Individually packed |
| CERTIFICATION & REPORTS | Compliance to Medical Device Rules (MDR) 2017 as amended till date | Yes |
| Availability of valid drug license for the product issued from the competent authority defined under Drugs and Cosmetic Act 1940 and Rules made there under as amended till date | Yes | |
| Manufacturing unit certification | ISO:13485 (Latest) | |
| Availability of Test Report for each supplied batch/product as per Medical Device Rule (MDR) 2017 as amended till date | Yes | |
| Submission of all necessary certifications, licenses and test reports to the buyer at the time of bid submission or along with supplies as per buyer requirement | Yes | |
| SHELF LIFE | Shelf Life from the date of manufacture (in months) | 24, 36 Or higher |
| Minimum shelf life of the product at the time of delivery to the consignee | 3/4 th of Total Shelf Life | |
| ADVANCE SAMPLE | Agree to provide advance sample of the product for buyer's approval before commencement of supply in case of bidding | Yes |
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