A-A-51884
23 March 1987
COMMERCIAL ITEM DESCRIPTION
CATHETER, CHOLANGIOGRAM (Plastic)
The General Services Administration has authorized the use of this commercial item description.
This commercial item description covers a cholangiography catheter to facilitate immediate postexploratory cholangiaography.
Salient characteristics:
Shall be a sterile, disposable, 4 French, 40 cm ± 2 cm long catheter specifically designed for intra-operative cholangiography. The cholangiography catheter shall be flexible. The cholangiography catheter shall be made of a clear, transparent plastic for visualization of air bubbles. The radiopaque ring shall be 1.5 cm from the tip opening for replacement determination of the catheter end near the common duct. The tube shall have a radiopaque stripe for its entire length except a portion of distal end. The cholangiography catheter shall have a beveled distal tip simplifying catheter insertion into the cystic duct.
The distal portion shall be cone-shaped with the flared proximal end of the cone being 0.5 cm from the catheter tip. It shall be designed to be held easily by an external suture and to prevent accidental withdrawal. The cone flange in the cystic duct shall be designed to minimize leakage of contrast media.
The cholangiography catheter shall be facilitated with two port Luer-lock fittings in accordance with ANSI/HIMA MD70.1 to allow dye and irrigation syringes to be attached simultaneously.
The French size shall be clearly marked on the catheter.
The cholangiography catheter shall meet any FDA requirements for safety and toxicity applicable for invasive and implantable devices in effect at the time of solicitation.
Workmanship. The cholangiography catheter shall be free from defects which detract from their appearance or impair its serviceability.
DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited.
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