A-A-30027
October 28, 1981
COMMERCIAL ITEM DESCRIPTION
The General Services Administration has authorized the use of this Commercial Item Description.
This medical device is a sterile lubricant that has multiple uses in surgical and non-surgical procedures.
SALIENT CHARACTERISTICS: This Commercial Item Description applies to preparations packaged in various sizes according to commercial practice, including unit of use and unit dose. The product shall be a sterile, bacteriostatic, glycerinated, greaseless, water-miscible, non-corrosive jelly suitable for use for lubricating instruments and devices to be used on human skin and membrane. In addition, the product shall be a clear, transparent, colorless non-irritating, non-sensitizing, non-toxic jelly and shall be completely compatible with the skin and mucous membrane of the anatomical passages. The lubricant shall have a pH of 4.0 to 7.0 at 25°C, and viscosity of not less than 20,000 centipoises and not more than 50,000 centipoises at 25 C. Materials used in manufacture shall be of a pharmaceutical grade and unit dose preparations shall be packaged in foil packets. For unit of use immediate container, the expiration dating shall be not less than 18 months remaining at time of delivery to the Government, and may range up to 60 months, as deemed appropriate by the contracting officer. For multiple use tube-type immediate container not more than 6 months shall have elapsed from the date of manufacture to date of delivery to the Government.
CONTRACTOR CERTIFICATION. The contractor shall certify that the product offered meets the salient characteristics of this description, and conforms to the producer’s own drawings, specifications, standards and quality assurance practices, and is the same as the product sold in the commercial marketplace. 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 ;hall comply, and be responsible for compliance by its subcontractors/ suppliers, with the requirements of the 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, and regulations.
Recovered materials. The offeror/contractor is encouraged to use recovered material in accordance with Public Law 94-580 to the maximum extent practical.
PRESERVATION, PACKAGING, PACKING, LABELING, AND MARKING: Unless otherwise specified, preservation, packaging, and packing shall be to a degree of protection to preclude damage to containers and/or contents thereof under normal shipping conditions, handling etc., involving shipment from the supply source to the receiving activity, plus reshipment from receiving activity, and shall conform to applicable carrier’s rules and regulations. Intermediate and exterior package quantities and labeling and marking shall be as specified in the contract and/or order.
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