00015151

Organization name

HOFFRICHTER GmbH

SRN

DE-MF-000004928

Manufacturer status

Active

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

• CW011

  EUDAMED did not publish a description for this code.
• CW010

  EUDAMED did not publish a description for this code.
• CW014

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.
• CW999

  Risk of injury due to contraindications! Respiratory therapy may be contraindicated for certain pre-existing conditions. These pre-existing conditions include: • Bullous lung disease • Pneumothorax • Very low blood pressure • Air accumulation following an open traumatic brain injury or other head injuries In case of a sinus infection or an infection of the middle ear, the doctor must verify that therapy may continue.

Primary placement in Bulgaria; available across 3 countries total.

Trade name

not provided

UDI-DI code

04250316301896

Basic UDI-DI

B-04250316301896

Reference / catalog number

00015151

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 device "TREND III" is used for non-invasive pressure-controlled breathing support. The device is suitable for the treatment of obstructive sleep apnea in patients over 30 kg, especially when required by higher pressures and / or forms of respiratory failure. Therapy pressure is administered via a breathing mask, which must be equipped with a passive exhalation valve to ensure exhalation air discharge. Use of the device is intended for home medical care and professional health care facilities such as sleep laboratories and hospitals.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Z12030102CONTINUOUS POSITIVE PRESSURE EQUIPMENT

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