MHC BACTERIAL/VIRAL FILTER(BULK PACKED)

Trade name

MHC BACTERIAL/VIRAL FILTER(BULK PACKED)

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

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06923980110269

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

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69239801ND2IBP8

Reference / catalog number

XTA0034

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

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GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

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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.

• R040101ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS

1 warning recorded — scroll inside the panel to see all entries.

• CW999

   Intended for use by qualified personnel trained in advanced pulmonary ventilation.  Always check that the filter is free from foreign bodies and moisture before use on a patient.  To avoid functional impairment and contamination, keep the medical device packaged until ready for use. Do not use the device if the packaging is damaged, unintentionally opened before use, or if it has been exposed to environmental conditions outside of those specified.  DO NOT reuse the disposable device. Failure to do so can result in the transmission of infectious agents and compromise patient safety.  DO NOT use the device if it is visibly damaged or has any cracks, tears, or holes. Using the damaged device can compromise the integrity of the device and lead to leaks, which can cause cross-contamination and potentially lead to patient harm.  DO NOT use the device that is not compatible with the specific equipment and ventilation mode being used. This can result in equipment malfunction and inadequate ventilation, which can be life-threatening.  DO NOT use the device that is past its expiration date or has exceeded its recommended number of uses. This can compromise the integrity and effectiveness of the device and lead to patient harm.  DO NOT use the device that has been stored improperly or exposed to extreme temperatures or other damaging conditions.  This product is for single patient use only and contains no reprocessable items. DO NOT attempt reprocessing.  When the filter is used on the patient side, DO NOT use it in combination with active humidification systems or medication nebulizers, as this may increase circuit resistance and pressure, potentially impairing patient ventilation.

No certificate specifically references this device's Basic UDI-DI.