Sinapi Chest Drain

Trade name

Sinapi Chest Drain

06009888639382

60099003867SCDW5

Reference / catalog number

XS50-D

GS1

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

The SINAPI Chest Drain (SCD) is a non-invasive medical device that is connected to any inserted chest catheter. It is a sterile, single use device, intended to drain fluid from the thoracic cavity.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

1 packaging level registered — each level carries its own UDI-DI.

• 06009888639382× 1 unitBase unit
  • 16009888639389× 10 units

European Medical Device Nomenclature — the EU product classification assigned to this device.

• A060203PLEURAL DRAINAGES WITH VALVE AND KITS

4 warnings recorded — scroll inside the panel to see all entries.

• Caution

  1. This device is only intended for use by appropriately trained personnel, familiar with thoracic surgical procedures and techniques, including chest drain use. 2. Do not use device in situations that require active suction in the pleural space. 3. Compatibility of the Sinapi Chest Drain with thoracic catheters needs to be established by the user. 4. Regularly assess the thoracic catheter connections for signs of an air leak. 5. Replace the XS50 chest drain if it is damaged or if there is evidence of occlusion. 6. Connect only ONE chest catheter per chest drain. 7. Do not clamp tube, this will inhibit drain operation and may compromise respiratory function of patient. 8. The needle-free sampling port located on the front of the device can also be used to drain fluid from the collection reservoir. 9. Observing Universal Precautions, discard the SCD in a medical waste container, in accordance with the Waste Management policy of the health care facility. 10. NOTE: Any serious incident that occurs in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.

• Do not resterilize
• Do not re-use

  Single use only

• Do not use if package is damaged