PRO-22 Automatic blood pressure monitor

Organization name

B.Well Swiss AG

SRN

CH-MF-000012588

Manufacturer status

Active

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

• CW999

  Do not use this device if the patient’s condition meets the following contraindications, to avoid inaccurate measurements or injuries.
• CW999

  The device is not suitable for use on patients with implanted, electrical devices, such as cardiac pacemakers and defibrillators.
• CW999

  Avoid taking measurement on the arm on the side of a mastectomy or lymph node clearance.
• CW999

  The device measures blood pressure using a pressured cuff. If the measuring limb suffers from injuries (for example open wounds) or under conditions or treatments (for example intravenous drip) making it unsuitable for surface contact or pressurization, do not use the device, to avoid worsening of the injuries or conditions.
• CW999

  Avoid taking measurements of patients with conditions, diseases, and susceptible to environment conditions that lead to incontrollable motions (e.g. trembling or shivering) and inability to communicate clearly (for example children and unconscious patients).
• CW999

  The device uses oscillometric method to determine blood pressure. The arm being measure should have normal perfusion. The device is not intended to be used on a limb with restricted or impaired blood circulation.If you suffer with perfusion or blood disorders, consult your doctor before using the device.

Primary placement in Lithuania; available across 4 countries total.

Trade name

PRO-22 Automatic blood pressure monitor

UDI-DI code

07640156398908

Basic UDI-DI

764015639MDA0203_2LB

Reference / catalog number

1101628

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

PRO-22 Automatic blood pressure monitor

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Z1203020302NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS

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

Certificate health across this manufacturer's portfolio.