Product Description | Ventury Medical Oxygen Mask |
Purpose | Venturi Oxygen is also known as an air-entrainment mask, is a medical device to deliver a known oxygen concentration to patients on controlled oxygen therapy |
Type | Pediatric |
Sterile | Yes |
Utility | Single use disposable |
Oxygen delivery concentrations | 24% (Blue) |
Material of body | PVC |
Light Weight ,Transparent | Yes |
Anatomically Shaped | Yes |
Adjustable Straps and Nose Clips | Yes |
Edges of Mask | Feathered |
Connecting Channel or Tubing | Yes |
Swivel Adaptor | Yes |
Venturi Connector | Single with different FIO2 settings |
Lock System provided for accurate oxygen delivery | Yes |
Type of Packing | Single Individually packed in Soft Wrap |
Compliance to Medical Device Rule (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 |
Valid Drug License Number | MFG/MD/2019/000059 |
Manufacturing unit certification | ISO: 13485 (Latest) |
Additional Voluntary Certification Available | MFG/MD/2019/000059 |
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 in months from the date of manufacture | 36 month |
Minimum shelf life of the product at the time of delivery to the consignee | 3/4th of Total Shelf Life |
The Product should have shelf life of at least 2/3rd of the total shelf life at the time of supply | Yes |
Additional Requirement | NA |