Product Description
Cook Medical G03301 - SET, PNEUMOTHORAX, 9F, 29CM, 18G, 20CM, TPT100, EACH
Pneumothorax Set ? Trocar
Used to Treat Spontaneous and Tension Pneumothorax.
Pneumothorax Sets Consist of:
- 1 stainless steel needle
- 1 radiopaque catheter
- 1 Chest Drain Valve
- 1 polyvinylchloride connecting tube
- 1 plastic one-way stopcock
Intended Use
Pneumothorax Sets are intended for relief of simple spontaneous or iatrogenic pneumothorax and tension pneumothorax.
| Order Number | Reference Part Number | Catheter Fr | Catheter Length (cm) | Catheter Sideports | Needle gage | Needle Length (cm) |
| G03301 | C-TPT-100 | 9 | 29 | 20 | 18 | 20 |
Features & Benefits
- Trocar placement.
- Adapter on tubing can be connected to a suction apparatus or the Cook Chest Drain Valve.
- Radiopaque catheter enhances
- x-ray visualization.
Contraindications
- Pneumothorax Sets are not recommended for large fluid accumulation or hemothorax.
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 |
Precautions
- This product is intended for use by physicians trained and experienced in emergency treatment of pneumothorax. Standard techniques for placement of pneumothorax catheters in the pleural cavity should be employed.
- Activate hydrophilic coating, if present, by wetting surface of device with sterile water or saline. For best results, maintain wetted condition of device during placement.
- The potential effects of phthalates on pregnant/nursing women or children have not been fully characterized and there may be concern for reproductive and developmental effects.
- Lung puncture may result in an air embolus, which could lead to ischemia or infarction of major organs including the brain or cardiac system.
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.
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