MorbideX® - Protective cushion Pediatric

Organization name

BenCorpp Srl

SRN

IT-MF-000023046

Manufacturer status

Active

Certificate health across this manufacturer's portfolio.

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

• CW010

  Wash your hands and clean your face carefully before applying MorbideX®. Gently place MorbideX® on the nasal bridge and cheekbones. Then place the CPAP and BIPAP mask over MorbideX® for a comfortable fit that minimizes leaks. Alternatively, you can apply MorbideX® directly to the edges of the mask before putting it on. Do not use if the device shows any signs of defect. Do not use if the package is opened or damaged.
• CW007

  EUDAMED did not publish a description for this code.
• CW011

  Non-sterile, mono-patient reusable product: after each application, wash the device with a neutral detergent and tap water. Keep the device in a ventilated place until the water has evaporated. It is recommended to replace MorbideX® at most every 30 days or after 60 re-uses. Once dry, place MorbideX® back in its packaging until the next use. Store in clean and dry place, at room temperature. Do not use on damaged skin.Do not use the product after the expiration date. The expiry date refers to the intact and correctly stored product. Destroy after use. Always follow medical practice and national requirements regarding biohazards when disposing of a used medical device. In case of undesirable effects, discontinue use, consult your doctor and inform the manufacturer. In the event of serious accidents occurring related to the use of the device MorbideX®, send a report to the manufacturer (info@bencorpp.com), to the Italian Ministry of Health or to the competent authority of the EU Member State in which the product has been used.

Primary placement in Italy; available across 32 countries total.

Trade name

MorbideX® - Protective cushion Pediatric

UDI-DI code

08056209010151

Basic UDI-DI

805620901mbxSC

Reference / catalog number

MBX-02

Issuing entity

GS1

Risk category

Class I

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

• R030180RESPIRATORY MASKS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES