00021100

Organization name

HOFFRICHTER GmbH

SRN

DE-MF-000004928

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.
• CW011

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

  Risk of injury due to contraindications! Respiratory therapy may be contraindicated in the case of certain pre-existing conditions. When assessing the relative risks and benefits of using this equipment, the clinician should understand that this device can deliver pressures up to 20 cmH2O. In the event of certain fault conditions, maximum pressure of 40 cmH2O is possible. Studies have shown that the following pre-existing conditions may contraindicate the use of CPAP therapy for some patients: • Severe coronary artery disease • Bullous Lung Disease • Pathologically Low Blood Pressure • Bypassed Upper Airway • Pneumothorax • Signs of a sinus or middle ear infection Caution should be used when prescribing CPAP therapy for susceptible patients such as those with: Cerebral Spinal Fluid (CSF) leaks, abnormalities of the cribriform plate, prior history of head trauma, and/or Pneumothorax. The use of positive airway pressure therapy may be temporarily contraindicated if you exhibit signs of a sinus or middle ear infection. Please note: In either case above, it can only be determined by a competent physician whether to use CPAP device. In the presence of contraindications, a doctor should check whether the therapy can still be continued.

Primary placement in Romania; available across 2 countries total.

Trade name

not provided

UDI-DI code

04250316301940

Basic UDI-DI

B-04250316301940

Reference / catalog number

00021100

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 POINT 3 device is used for non-invasive pressure-controlled respiratory support in spontaneously breathing patients. The device is suitable for the treatment of obstructive sleep apnoea in patients with a body weight over 30 kg. The therapy pressure is administered via a breathing mask, which must be equipped with an exhalation valve to ensure the discharge of exhaled air.

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