A-A-53504B
The main bag shall be constructed of two sheets of suitable flexible plastic, heat sealed on all edges and vented at the top or in the catheter adapter in a suitable manner. The bag shall have a capacity of at least 2000 or 2500 cubic centimeters (cc) according to the size supplied. The bag shall not leak, or burst at a pressure less than 150 mm Hg.
The bag urometer shall be fabricated from a clear plastic material to permit the viewing of flow and contents. The urometer shall be either integral or adequately attached to the main drainage urine container. A drain shall be mounted at the bottom of the urometer to facilitate aseptic withdrawal of urine and shall include on-off control mechanisms affixed to the drain tube which will not cut the tube in operation.
The inlet tube shall have a minimum wall thickness of 0.040 inch and shall be permanently attached to the catheter adapter and the inlet port. The catheter adapter shall be fitted with a suitable tapered connector for attachment to a catheter and have a tip protector. The tubing shall be of sufficient length and sufficiently clear to view flow and contents.
The drain tube assembly shall be permanently attached to the bottom of the main bag. The drain tube shall be designed to be drip-proof and to facilitate aseptic withdrawal of urine and shall include on-off control mechanisms affixed to the drain tube which will cut the tube in operation.
The main bag graduations for all sizes shall be in 100 cc steps, beginning at 100cc. The size 1 main bag graduations shall end at not less than 2000 cc, but not more than 2500 cc. The size 2 main bag graduations shall end at not less than 2000 cc but not more than 2500 cc. At least every other main bag graduation, beginning at not greater than 100 cc, shall be identified. Identification of additional main bag graduation shall be permissible. The volumetric accuracy of the main bag graduations shall be at least ± 10%.
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