Neumofilt Ergo Pack Confort Plus

Organization name

Medical Respiratory Devices S.L

SRN

ES-MF-000000824

Manufacturer status

Active

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

• Warnings: 1. In case of any serious incident that has occurred in relation to the device, It should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established. For more report information see: https://health.ec.europa.eu/medical-devices-sector/new-regulations/contacts_en. 2. Verify that the diameter of the filter connection matches the diameter of the pulmonary function testing equipment. 3. Store filters in a clean, dry environment away from sources of heat or direct light. Handle the device with clean hands to avoid contamination. Users are recommended to wear disposable gloves when handling the filter. 4. Before use, verify that the device is not damaged, perforated or contaminated. Discard filters with any signs of damage or deterioration. 5. Incorrectly placing the filter in the pulmonary function testing equipment may result in inaccurate readings or lack of adequate protection against contamination 6. The duration of regular PFT are around 15-20 minutes. 7. Dispose of the device at the end of its useful life in accordance with local regulations on medical device waste. Do not waste it in general waste, as it may represent a risk to health and the environment.

  OTHER

• Precautions: 1. The filter, nose clip and mouthpiece are disposable intended for one patient during single pulmonary function testing. They should not be reused even for the same patient in different pulmonary function test, as this increases the risk of cross-contamination and may compromise the filter's effectiveness. 2. The filter neither the nose clip and mouthpiece cannot be cleaned or sterilized after use. Device should be discarded after the PFT procedure. Contraindications: 1. Potential relative and absolute contraindications for the pulmonary function testing (PFT) should be evaluated carefully by healthcare professional for particular patient. 2. Patients with pacemakers do not have an absolute contraindication to lung function testing However, it is important to inform the physician about the presence of the pacemaker before performing the lung function test. 3. Not for use in patients known to be allergic to any of the device components.

  OTHER

Primary placement in Spain; available across 10 countries total.

Trade name

Neumofilt Ergo Pack Confort Plus

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.

08436557231208

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.

843655723NEUMOFILTPCPVQ

Reference / catalog number

1536N03M

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.

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.

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

https://www.medicalrd.com/

Clinical sizes

• 28.6 MU50
• 30.9 MU50

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

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

• R049001PULMONARY FUNCTION TEST FILTERS

• Class IIa medical devices in EUDAMED

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