A-A-51544
All components shall contain no sharp edges that may injure the body during use or any ingredient known to be a skin irritant.
One complete fountain syringe shall be individually packaged in a sealed plastic bag, free from cuts and tears. The contents of the sealed plastic bag shall be clean and contain no foreign matter.
Each sealed plastic bag containing one syringe shall contain completer and clear instructions for use.
Workmanship. The fountain syringe and components shall be free from defects with detract from their appearance or impair their serviceability.
Unit. Package (PG). One package containing 24 individually packaged fountain syringes, plus two one-shot cuff inflators and one air bulb patient insufflators, as specified, constitutes one unit.
Contractor 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 Federal Food, Drug and 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.
Recovered materials. The offeror/contractor is encouraged to use recovered materials in accordance with Public Law 94-580 to the maximum extent practical.
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