Cook Medical G00130 - CATHETER, POLYTHYLN, ANG, P5.0-35-65-P-NS-0, 5/BX

Cook Medical G00130 - CATHETER, POLYTHYLN, ANG, P5.0-35-65-P-NS-0, 5/BX

Polyethylene Catheter

Used in angiographic procedures by physicians trained and experienced in angiographic techniques.

• Polyethylene material softens during prolonged catheter manipulation.
• Flexible cathter material recommended for low to medium pressure applications

Order Number	Reference Part Number	Fr	Accepts Wire Guide Diameter (inch)	Length (cm)	Tip Configuration
G00130	P5.0-35-65-P-NS-0	5.0	.035	65	Straight

This Product Line Is Serviced by The Following Clinical Division(S):

• Peripheral Intervention

Clinical Speciality

• Interventional Cardiology
• Interventional Radiology
• Vascular Surgery

Intended Use

The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed.

Precautions

• Manipulation of catheter requires fluoroscopic control.
• Due to thinwall construction, extreme care must be exercised during manipulation and withdrawal. Catheter insertion through a synthetic vascular graft should be avoided whenever possible.
• Do not attempt to heat or reshape the catheter curve; the catheter tip is made from a heat-sensitive material.
• The possible whiplash effect of the long, soft catheter tip must be considered during selective angiography.
• Activate hydrophilic coating, if present, by wetting the distal end of the catheter with sterile water or saline. For best results, keep the catheter surface wet during placement.
• If an over-the-wire catheter design is used, where the wire is left in place during injections, the proximal end of the wire should be clamped to protect against accidental injection of the wire guide.

Sterilization

Device Packaged as Sterile:	Yes
Requires Sterilization Prior to Use:	No

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

How Supplied

Supplied sterilized by ethylene oxide gas in peel-open packages. Intended for one-time use. Sterile if package is unopened or undamaged. Do not use the product if there is doubt as to whether the product is sterile. Store in a dark, dry, cool place. Avoid extended exposure to light. Upon removal from package, inspect the product to ensure no damage has occurred.