SYNC FLOW CANNULA L

Organization name

GINEVRI srl

SRN

IT-MF-000034527

Manufacturer status

Active

Certificate health across this manufacturer's portfolio.

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

• CW020

  EUDAMED did not publish a description for this code.
• CW009

  EUDAMED did not publish a description for this code.
• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Italy; available across 32 countries total.

Trade name

SYNC FLOW CANNULA L

UDI-DI code

08053847362819

Basic UDI-DI

B-08053847362819

Reference / catalog number

13226E73

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

The SYNC FLOW CANNULA is a dedicated non-invasive ventilation flow sensor patient interface for the GIULIA neonatal ventilator (NCPAP, NSIPPV, NIPPV, NSIMV). The interface is used to supply humidified and heated respiratory gas and includes a flow sensor for synchronised non-invasive ventilation of term and premature infants. The SYNC FLOW CANNULA is applied to the neonate by inserting the cannula into the orifices of the nose to deliver respiratory gas and promotes non-invasive ventilation; promoting gas exchange without causing any particular damage to the ventilated lung. Artificial ventilation in the newborn is usually a temporary measure to support lung function until complete spontaneous ventilatory autonomy is achieved. Its objectives are: - Provide adequate alveolar ventilation with CO2 removal and satisfactory oxygenation; - Reduce respiratory work. Recent guidelines and studies demonstrate the importance of non-invasive ventilation. Product intended for use on premature infants and neonates requiring supplemental oxygen, respiratory support or assistance in breathing in ambulatory and hospital settings.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• Large

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

• R02010102BREATHING CIRCUITS, WITH WATER TRAP