COMMERCIAL ITEM DESCRIPTION A-A-51636A
The plunger tip shall be lubricated with pharmaceutical grade silicone lubricant. The plunger shall make a good seal between the barrel and plunger such that there shall be no leakage past the plunger in either direction.
The plunger tip shall have a minimum of two rings making contact with the barrel. The distal tip ring shall accurately indicate the syringe fluid volume on the barrel scale. The plunger tip shall be of a color which clearly contrasts with the syringe barrel for maximum visibility. The proximal end of the plunger shall have a thumb grip.
Each syringe shall be supplied with 38 inches ± 4 inches of tubing. A vented conical spike with a bacterial filter shall be permanently attached to the distal end of the tubing. The tubing shall have a hardness of 77 ± 5 Shore A durometer. A two-way valve shall be permanently attaché in a leakproof manner to the tubing. The two-way valve shall prevent liquid from entering the tubing when the syringe is being emptied and prevent air from entering through the needle (needle not provided) when the syringe is drawing liquid from a container via the tubing. The proximal end of the two-way valve shall have a female Luer lock adapter. The distal end of the two-way valve shall be a male Luer lock adapter. An on-off clamp shall be provided on the tubing.
End protectors shall be provided on the syringe outlet, two-way valve inlet and outlet and the spike. Each end protector shall be readily removable. When placed over each open end it shall, after sterilization, maintain sterility and integrity of the entire fluid path of the device until manually removed. As an alternate, if the syringe is supplied with the two-way valve assembled, one two end protectors are required, one on the spike and one on the two-way valve outlet.
Marking. Syringes shall bear the manufacturer’s name or registered trademark and the capacity in milliliters (ml) or cubic centimeters (cc).
Luer fittings. The Luer fittings shall meet the dimensional and performance requirements of ANSI/HIMA MD70.1.
Instructions. An instruction sheet detailing the proper use of the syringe shall be provided with each device.
Workmanship. The syringe set shall be free from defects which may detract from its appearance or impair its serviceability. The lumina shall be void of any obstructions.
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