HEAT AND MOISTURE E

This contract specifies the procurement of a single-use heat and moisture exchanger designed for humidification. The device features a two-part humid-vent design with a transparent housing for visibility and is optimized for tidal volumes ranging between 150ml and 1500ml. The items must be delivered in commercial packaging that protects against damage, utilizing suitable exterior shipping containers for safe transport. All materials must adhere to Medical Marking Standard No. 1, and labels must clearly display the manufacturer date, expiration or retest date, and the contract or lot number. The procurement requires a total of three packages, with each package containing 20 individual units. The product has a non-extendable shelf life of 60 months, and no more than nine months of that shelf life may have elapsed between the date of manufacture and the date of delivery to the government. This is an FDA-regulated Class I device requiring compliance with registration, listing, labeling, and Good Manufacturing Practices. Delivery is required within 20 days to the specified destination, with inspection and acceptance occurring at the point of delivery.