Braun ExactFit 1, BUA4000EU

Organization name

KAZ Europe Sàrl

SRN

CH-MF-000029980

Manufacturer status

Active

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

• CW018

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

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

  This device has not been tested for and hence is not intended for neonatal and infant subjects, pregnant, including pre-eclamptic users. This blood pressure monitor is not intended for clinical use in a professional environment and is for home usage only. The use of this blood pressure monitor is not intended as a substitute for a consultation with your doctor.
• CW999

  Measurement errors may occur if the original cuff is not used.People suffering from cardiac arrhythmia, vascular constriction, arteriosclerosis in the extremities, diabetes or users of cardiac pacemakers should consult their doctor before measuring their blood pressure themselves. Deviations in blood pressure values may occur in such cases. If your blood pressure reading is in the severe hypertension range with values of 180 mmHg systolic and above, and/or 110 mmHg diastolic and above; and you find you have one or two readings in this range - please see your doctor straight away.If you are under medical treatment or taking any medication, please consult your doctor first. Avoid compression or restriction of the connection tubing. Continuous cuff pressure due to the connection tubing kinking can affect blood flow and cause possible injury to the user.
• CW999

  It is not recommended to use this device on the arm of the same side of the body on which the user had a mastectomy. Measuring blood pressure too frequently can cause injury to the user due to blood flow interference. It is not recommended to apply the cuff to a limb on which there is intravasular access or on which an arterio-venous (A-V) shunt is present. This can cause temporary interference of blood flow and potential injury to the user. DO NOT apply the cuff over a wound as this can cause further injury. It is not recommended to use the device while simultaneously using other medical electrical (ME) equipment on the same limb.

Primary placement in Belgium; available across 12 countries total.

Trade name

Braun ExactFit 1, BUA4000EU

UDI-DI code

07630759300095

Basic UDI-DI

76307593BP4000CJ

Reference / catalog number

BUA4000EU

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

Upper Arm Blood Pressure Monitor

Additional information URL

https://www.helenoftroy.com/emea/

Clinical sizes

• +18 years old
• Cuff size : 22-42cm

• Z1203020302NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS

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