Organization name

MEKICS Co., Ltd

SRN

KR-MF-000012640

Manufacturer status

Active

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

• CW999

  1. The HFT700 ventilator must only be used: - For the intended treatment specified in this manual and the instructions given by the responsible clinical personnel. - In accordance with the operating conditions specified in this manual. - Accessories specified or approved by MEKICS must be used in an unmodified state. Other uses may lead to risk of patient injury! 2. Whenever using the HFT700 ventilator, have immediate access to an alternative means of ventilation, such as another ventilator device or assisted ventilation. In case of a device failure or problems encountered while assisting a patient’s respiration with the HFT700 ventilator, remove the device from the patient and immediately replace it with another ventilator device. 3. Use the HFT700 ventilator on patients capable of spontaneous breathing. While oxygen therapy through the HFT700 ventilator or assist ventilator may be helpful to a patient’s respiration, it is not intended to provide for the total ventilatory requirements of the patient. 4. We do not recommend use of the HFT700 Ventilator on patients who require ventilation at precise tidal volumes. The device provides a high flow (HF) mode and is indicated for assisted ventilation only. These modes do not provide ventilation with precise tidal volume delivery

Primary placement in Italy; available across 32 countries total.

Trade name

HFT700

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.

08809268918599

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.

B-08809268918599

Reference / catalog number

MCN-WM-1851

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 IIb

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

This device is a medical device to provide spontaneously breathing patients with respiratory failure with high-flow nasal cannula therapy.

Additional information URL

https://mek-ics.com/

Clinical sizes

No clinical sizes registered for this device.

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

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

• Z12030104PORTABLE PULMONARY VENTILATORS

• Class IIb medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.