00013091

Organization name

HOFFRICHTER GmbH

SRN

DE-MF-000004928

Manufacturer status

Active

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• CW011

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• CW010

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• CW007

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• CW014

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• CW999

  Ventilation may be contraindicated for certain pre-existing conditions. General: • Severe cardiac arrhythmia • Severe hypotension • Severe epistaxis • Pneumothorax or pneumomediastinum • Pneumoencephalus • High risk of barotrauma • Head trauma • Status after cranial or brain surgery • Acute sinusitis, middle ear infection or a perforation of the eardrum Absolute contraindication to non-invasive-ventilation (NIV): • Lack of spontaneous breathing or gasping for breath • fixed or functional obstruction of the airway • gastrointestinal haermorrhage or ileus Relative contraindication to non-invasive-ventilation (NIV): • Coma • Massive agitation • Massive retention of secretions despite bronchoscopy • Severe dysphagia (bulbar dysfunction) with risk of aspiration • Severe hypxaemia or acidosis (pH < 7,1) • Haemodynamic instability (cardiogenic shock, myocardial infarction) • Anatomical and/or subjective interface incompatibility • State after upper gastrointestinal OP. If contraindications are present, a doctor should check whether the therapy can still be continued.

Primary placement in France; available across 4 countries total.

Trade name

not provided

UDI-DI code

04250316301865

Basic UDI-DI

B-04250316301865

Reference / catalog number

00013091

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The LAVI ventilator may only be used for non-life-sustaining ventilation. It is used for intermittent respiratory support and for ventilating patients with sufficient spontaneous breathing capacity. The device is suitable for the care of adults and children with a tidal volume of 100 ml or more and can be used in home health care settings and/or in professional health care facilities. It must not be used for intensive care ventilation. The LAVI 45 ventilator can be used invasively and non-invasively.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Z12030103PULMONARY VENTILATORS FOR NON–HOSPITAL USE

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