00013135

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 Germany; available across 1 country total.

Trade name

not provided

UDI-DI code

04250316301964

Basic UDI-DI

B-04250316301964

Reference / catalog number

00013135

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 35 ventilator is for non-invasive use only, using a ventilator mask with an exhalation valve (vented) or a ventilator mask without an exhalation valve (non-vented) in conjunction with a passive exhalation valve which must be attached to the CPAP tube to be used so that the exhaled air can escape.

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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