A-A-51595 Catheter, Cardiovascular, Irrigation

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A-A-51595

5 August 1986

COMMERCIAL ITEM DESCRIPTION

CATHETER, CARDIOVASCULAR, IRRIGATION

The General Services Administration has authorized the use of this commercial item description.

This commercial item description covers an irrigation catheter suitable for cardiovascular procedures.

Salient characteristics:

The catheter shall be sterile disposable, cardiovascular irrigation catheter of the Fogarty style, suitable for irrigation during embolectomy procedures. The catheter shall be fabricated of a flexible plastic which meet the requirements of the USP for Class IV plastic. The catheter shall be 4 French size and 80 ± 5 centimeters (cm) in length with markings at each 10 cm increment. The catheter shall be radiopaque in accordance with ASTM F640. The size and length of the catheter shall be identified at the proximal end. Also, the proximal end shall have a female Luer lock connection in accordance with ANSI/HIMA MD70.1. The distal end of the catheter shall have a smooth, round tip to reduce vessel trauma, and have a suitable orifice admitting irrigating fluids.

The catheter shall be provided with a sterile, disposable 3 to 5 milliliter (ml) syringe fabricated of a rigid plastic which meets the requirements of the USP for Class II plastic.

The catheter shall meet the requirements of the USP for transfusion and infusion assemblies. The catheter shall have at least two years of shelf life remaining at the time of delivery to the Government.

Workmanship. The catheter shall be free from defects which detract from their appearance or impair its serviceability.

Unit.  Each (EA). One cardiovascular catheter with syringe, as specified, constitutes one unit. The catheter and syringe shall be packaged sterile in a sealed peel-open package which allows aseptic handling and maintains sterility until opened or damaged.

DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited.