SpeVaX® - Trach-HME with Built-in Speech Valve

Organization name

BenCorpp Srl

SRN

IT-MF-000023046

Manufacturer status

Active

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

• CW007

  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.
• CW011

  Non-sterile, single use only: do not sterilize or reuse, as the intended function will be affected, and this might increase the risk of possible transmission of infection. 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 SpeVaX® Trach-HME with Built-in Speech Valve, 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.
• CW018

  Do not use beyond recommended tidal volume range, as the added dead space may cause CO2 retention at too low tidal volumes. A too high tidal volume may lead to unsatisfactory humidification.Do not use on dehydrated patients or patients with very heavy secretions from the lungs and airways.

Primary placement in Italy; available across 32 countries total.

Trade name

SpeVaX® - Trach-HME with Built-in Speech Valve

UDI-DI code

08056209010113

Basic UDI-DI

805620901svhU6

Reference / catalog number

SVH50

Issuing entity

GS1

Risk category

Class IIa

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.

• R040201TRACHEOSTOMY HUMIDIFIERS

Certificate health across this manufacturer's portfolio.