Organization name

SINAPI Biomedical (Pty) Ltd

SRN

ZA-MF-000012126

Manufacturer status

Active

No certificate specifically references this device's Basic UDI-DI.

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

Primary placement in Austria; available across 15 countries total.

Trade name

Sinapi Chest Drain

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

06009900386706

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

60099003867SCDW5

Reference / catalog number

XS50

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

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.

• 06009900386706× 1 unitBase unit
  • 16009900386703× 25 units

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

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

• A060203PLEURAL DRAINAGES WITH VALVE AND KITS

• Class I medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.