009989

Organization name

Breas Medical AB

SRN

SE-MF-000001061

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW011

  Use only with continuous airflow. Do not block the leak port or anti-asphyxia valve. Patients unable to remove the mask must use it only under qualified supervision and clinician advice. Stop use if adverse reactions occur.

Primary placement in Sweden; available across 20 countries total.

Trade name

not provided

UDI-DI code

07321820099894

Basic UDI-DI

732182219999BM

Reference / catalog number

009989

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

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• Large

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

European Medical Device Nomenclature — the EU product classification assigned to this device.

• R0301010201CPAP MASKS
• R0301010202NIV MASKS