General information
For liquids and/or air drainage and aspiration from the stomach (gastric area).
For feeding adults and older children.
For gastric lavage.
For surgical illeus; application of conservative treatment using gastric decompression.
Specifications
A single hollow cylinder introduced into the gastrointestinal (GI) tract, nasally or orally, for aspiration or feeding.
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Materials: |
Polyvinyl chloride (PVC) |
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Single channel tube with conical or funnel tip. |
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Tube: Transparent, with X-ray radio-opaque markings at 40, 50, 60 and 70cm from the distal end, corresponding to the cardia, stomach, duodenum and jejunum. |
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- Patient end: soft, rounded closed-ended tip, and 4 lateral opposite the alternative eyelets. |
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- Size: Diameter CH06 to CH20, length 120-125cm. |
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Connector: funnel or cup tip to fit aspiration system or drainage bag. |
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Unit presentation: |
1 gastric tube, sterile, single-use, peel pack. |
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Primary packaging: |
Peel pack. |
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Labelling: Manufacturer’s name and/or trademark, "sterile", lot number, expiry date by year and month, "for single use", CE mark plus reference number for notifying body, product description, and instructions for use. Must be multilingual: English, French and Spanish, others when available. |
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Secondary packaging: |
Protected unit, one (1) box with 20- or 50-unit presentation. Labelling is the same as primary packaging. |
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Additional required information: Number of units per secondary packaging. Information for product-specific storage conditions (e.g., temperature, pressure, light, humidity, etc.) and user recommendations. |
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Other requirements: |
Norms: Must comply with: |
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- Medical Device Directive 93/42/EEC, risk class IIa |
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- EN 1615: Enteral feeding catheters and enteral giving sets for single use and their connectors - Design and testing |
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- EN 550 gas sterilization ethylene oxide |
NOTE:
- Can be used with a syringe with conical nozzle (i.e., syringe, disposable, conical, 100ml, MINSSYRD100) for manual suction, tube feeding or gastric aspiration during surgery.
- Can also be used with suction, foot-operated (anaesthesia) and suction machines, or a pump.
A bi-conical connector is required to connect to the suction tubes: MCTDCONS7S CONNECTOR, biconical, fits tubing with 7-14mm diameter, sterile , disposable.
- A urine bag can be used as a collector (MCTDBAGU2L).