LiMAx Breathing Mask Set A

Organization name

Humedics GmbH

SRN

DE-MF-000005094

Manufacturer status

Active

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

• CW009

  Do not re-use
• CW011

  Do not apply the LiMAx test to patients with known allergic reactions to methacetin or paracetamol. The breathing mask is made of latex-free silicone rubber. Due to its high tolerability in contact with patients, this material is standard in the clinical field. Nevertheless, in a small number of cases, intolerances to silicone may occur when using the breathing mask. In such cases, special precautions, such as applying a protective gel (e.g. hydrocolloid dressings) between the mask and the patient's face, are required to perform the LiMAx test. In cases of highly urgent indication and suspected serious lung infection with highly multi-resistant microbes or open tuberculosis, if a LiMAx test is deemed medically necessary then an adequate, standard bacteria filter must be fitted between the breathing tube and the connection to the LiMAx measurement device.

Primary placement in Germany; available across 3 countries total.

Trade name

LiMAx Breathing Mask Set A

UDI-DI code

09120087610068

Basic UDI-DI

912008761HUM100088

Reference / catalog number

201002M

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

https://www.humedics.de/

Clinical sizes

No clinical sizes registered for this device.

• R030199RESPIRATORY MASKS - OTHER

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