BONNET for NIV size L Ø 35cm - Blue (Pack of 6)

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.

• CW009

  EUDAMED did not publish a description for this code.
• CW020

  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 1 country total.

Placed on the market in Italy; per-country availability dates not published.

Trade name

BONNET for NIV size L Ø 35cm - Blue (Pack of 6)

UDI-DI code

18053847360515

Basic UDI-DI

80538473616SP

Reference / catalog number

11659D73

Issuing entity

GS1

Risk category

Class I

Applicable legislation

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

Status

On the market

Quantity

6

Additional product description

The BONNET for NIV has been designed to provide effective and comfortable securement of various types of interfaces for non-invasive ventilation of small patients in neonatal and paediatric wards. It features various fastening systems: Two side tabs with corresponding Velcro straps allow the position of the interface to be adjusted and maintained in accordance with the patient’s anatomical shape. A central tab is used to connect the front of the respiratory circuit in a manner that integrates with the patient’s head movements, whilst allowing the patient the necessary freedom of movement. A coloured tab at the end of the BONNET allows the top of the BONNET to be opened and closed, facilitating cleaning procedures and/or diagnostic activities (e.g. brain echocardiography). The BONNET is made of medical-grade cotton with external seams for maximum patient comfort. The fastening tabs are made of special, dedicated Velcro, which is particularly soft to prevent skin abrasions. To reduce the risk of contamination, it is recommended for single-use only.

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.

• T0207CAPS AND HEADWEAR (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE)