A-A-51384B
Unit.
Size 1 – Package (PG). Shall be supplied in a commercially available vial. One package containing 10 vials, as specified, constitutes one unit.
Size 2 – Package (PG). Shall be supplied in a commercially available piggyback vial of sufficient volume to allow for reconstitution. One package containing 10 vials, as specified, constitutes one unit of issue. Each vial shall be compatible with the following stocklisted IV administration sets: 6515-00-088-8868, 6515-00-117-9021, 6515-00-118-1341, 6515-01-107-1201, and 6515-01-433-2089.
Size 3 – Package (PG). Shall be supplied in a vial with a rated capacity of not less than 100 ml accompanied by a suitable hanging device which allow the bottle to be hung for intravenous admixtures programs. One package containing one vial and one hanging device, as specified, constitutes one unit.
Size 4 – Package (PG). Shall be supplied in a vial with a rated capacity of not less than 100 ml accompanied by a suitable hanging device which allow the bottle to be hung for intravenous admixtures programs. One package containing 10 vials and ten hanging devices, as specified, constitutes one unit.
Contactor certification. The contractor shall certify that the product offered meets the salient characteristics of this description and conforms to the producers’ own drawings, specifications, standards, and quality assurance practices. The Government reserves the right to require proof of such conformance prior to first delivery and thereafter as may be otherwise provided for under the provisions of the contract.
Regulatory requirements.
Federal Food, Drug, and Cosmetic Act. If the product covered by this document has been determined by the U.S. Food and Drug Administration to be under its jurisdiction, the offeror/contractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of the Federal Food, Drug Cosmetic Act, as amended, and regulations promulgated thereunder. In addition, the offeror/contractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of all other applicable Federal State, and local statutes, ordinances, and regulations.
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