Sinapi urimeter

Trade name

Sinapi urimeter

06009900386782

60099003867SUM500V2Y4

Reference / catalog number

SUM500V2

GS1

Class I

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The Sinapi urine meter is manufactured from polymers with hydrophobic properties. In the rigid container, collected fluid is measured and recorded hourly. The contents of the rigid container is emptied into the collection bag so that fluid from the next hour can be collected.

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.

• 06009900386782× 1 unitBase unit
  • 16009900386789× 20 units

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

• A06030399URINE COLLECTION SYSTEMS - OTHER

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

• Caution

  • Only appropriately trained personnel may use this device. • Needles will damage the needle-free port and must not be attached to syringes in order to collect samples from the needle-free port. • Aseptic technique must be used when obtaining urine samples. • The drainage system must remain below the level of the bladder. • Tension on the urine catheter must be avoided by securing the drainage system to the patient’s upper leg. • Ensure unobstructed urine flow by preventing kinks in the tubing of the drainage system. • The tap of the urine collection bag must not touch the floor. • Observing Universal Precautions, discard the SUM in a medical waste container, in accordance with the Waste Management policy of the health care facility. • 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 use if package is damaged
• Do not re-use

  Single use only

• Do not resterilize