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. ContraindicationsThis device is contraindicated for use when:A patient is incapable of spontaneously breathing and shows signs of severe respiratory failure. One cannot ensure the patient’s free airways or remove secretions. There is a risk of inhaling gastric secretion. The patient has acute sinusitis or otitis media. The patient is allergic to materials in the nasal cannula or has a history of hypersensitivity to them. The patient has nosebleeds following pulmonary aspiration. The patient has hypotension. 2. Critical WarningsNot for Life Support: The HFT750 is not suitable for the entire ventilatory demand of a ventilator-dependent patient. Explosion/Fire Hazard: Do not use this device near combustible gases. The oxygen-enriched environment accelerates flammability. MR Unsafe: Do not use the HFT750 ventilator in an MRI (Magnetic Resonance Imaging) environment. Keep it outside the MRI scan room.

Primary placement in Italy; available across 32 countries total.

Trade name

HFT750

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.

08809268914294

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.

880926891Z12030104H3N

Reference / catalog number

MCN-WM-1875

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

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

Status

On the market

Quantity

1

Additional product description

The HFT750 ventilator (PCV, PSIMV, VCV, VSIMV, SPONT, CPAP and bi-level Mode) is a medical device to assist patients in breathing. This portable ventilator is intended for spontaneously breathing individuals who require mechanical ventilation. These patient groups also include patients with respiratory failure, chronic respiratory failure, or obstructive apnea. This device (HF function) assists the patient’s respiratory therapy by providing the spontaneously breathing patient with respiratory gas heated and humidified with a higher flow than the patient’s ventilatory demand. This includes patients who have had their upper airways bypassed. The flow delivered to the patient may be from 1 – 60 l/min depending on the interface used. The device is intended to support pediatric patients weighing 12.5 kg or greater to adult patients in non-invasive respiratory therapy. For HF mode, it can be used for patients of all ages weighing more than 3 kg. The device must be used by qualified medical professionals, such as physicians, nurses, and respiratory therapists. In addition, the combinations of the patient’s breathing circuit, interfaces (masks and nasal cannula), and other accessories must follow MEKICS’s recommendations.

Additional information URL

http://www.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.