General information
For non-operative drainage (temporary or long-term) of the urinary bladder when passage of a urethral (Foley) catheter is not possible: enlarged prostate, fracture of the pelvis with rupture of the prostate urethra, injury to penis, and obstetric perinea trauma (fistulae).
A suprapubic catheter is basically an indwelling catheter inserted directly into the bladder through the abdomen, above the pubic bone. It must be inserted by a physician.
Specifications
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A suprapubic urological catheter (plus accessories) is a flexible tubular device that is inserted through the abdominal wall into the urinary bladder with the aid of a trocar and cannula. |
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Complete set for inserting suprapubic catheter. |
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Components: |
1 catheter: pigtail end, with balloon, semi |
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1 puncture needle, trocar |
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1 scalpel |
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1 urine bag 2 litres |
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1 clamp or plug |
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1 adhesive tape |
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Materials: |
Catheter: 100% silicone |
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Puncture needle: trocar stainless steel. |
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Urine bag: polyvinyl chloride (PVC) |
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Specifications: |
Semi-flexible hollow cylindrical tube with central channel (for urine drainage) and a side channel (to inflate the balloon) ending in a none-return valve device with a Luer connection. |
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Catheter: |
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- Length: 510-650mm with 6 lateral eyes and curled open tip (pigtail) to act as an anchor in the bladder. |
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- Diameter: CH10 (3.3mm), CH12 (4mm), CH16 (5.3mm) |
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Balloon: 3-5ml (CH10), 2-10ml (CH12), 5-15ml (CH16), connected with |
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Puncture needle: to perforate the abdominal wall to the depth of the bladder, enabling insertion of a catheter. |
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- Pre-split sheath, with a long, sharp lance-shaped tip. |
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- Colour code on wings: white CH10, green CH12, orange CH16 |
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Urine bag: 2-litre volume with 100ml graduated scale, kink-resistant tubing, emptying-valve system and tubing clamp. |
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Plug: to close suprapubic catheter when required. |
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Adhesive tape: adapted to catheter size for quick and safe attachment to abdominal wall. |
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Initial sterilization: ethylene oxide (EO) |
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Unit presentation: sterile, peel-pack, single-use |
MCTDSSUPR16: Suprapubic replacement set CH16, complete
- 1 catheter, as described above.
- 1 wire guide: 1.1mm diameter, length 1000mm
Material: chrome nickel stainless steel,
Shape: spiral
- 1 body guide: highly flexible, with an atraumatic and rigid extremity
- 1 catheter stopper
- 1 adhesive tape, as described above
Sterilization: Ethylene oxide (EO).
Unit presentation: sterile, peel pack, single use
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Packaging |
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Primary packaging: |
Should mention: Manufacturer’s name and/or trademark, the word "sterile", lot number, expiry date by year and month, "for single use". CE plus reference number of notifying body, product description, all multilingual. |
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Secondary packaging: |
Protected unit: One box with 5-unit presentation, labelling must be the same as that of the primary packaging. |
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Required additional information: Number of units per secondary packaging. Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate. User instructions, multilingual (English, French and Spanish, others when available). |
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Over packaging: |
Packaging unit, strong carton. |
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Other requirements: |
Complies with directive MD 93/42/EEC, risk class II. |
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Conform to norm |
EN 1617 catheters, other than intravascular catheters.
- Test methods for common properties
- EN 1618 Sterile drainage catheters and accessory devices for single use
- EN ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. |