Organization name

SINAPI Biomedical (Pty) Ltd

SRN

ZA-MF-000012126

Manufacturer status

Active

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

• Do not resterilize
• Do not re-use

  Single use only

• Do not use if package is damaged
• Caution

  1. This device is only intended for use by appropriately trained personnel, familiar with thoracic surgical procedures and techniques, including the use of chest drains. 2. This device is not intended for Paediatric use. 3. Do not use this device in circumstances that require active negative pressure (suction) in the pleural space. 4. Compatibility of LEVO with thoracic catheters needs to be established by the user. 5. Regularly assess thoracic catheter connection for any signs of air leak. 6. Replace the LEVO if it is damaged or if there is evidence of occlusion. 7. Connect only ONE chest catheter per chest drain. 8. Do not clamp the tubing during chest drainage, this will inhibit drain operation and may compromise respiratory function of patient. If clamping is required, temporarily kink the tubing by hand. 9. Observing Universal Precautions, discard LEVO 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.

Primary placement in Austria; available across 16 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.

06009888639399

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

XS100

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.

• 06009888639399× 1 unitBase unit
  • 16009888639396× 10 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

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

Certificate health across this manufacturer's portfolio.