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Organization name
UDI-DI code
Reference / catalog number

LiMAx Breathing Mask Set B — Class IIa MDR by Humedics GmbH

MD Atlas
Humedics GmbH

EUDAMED last updated this device on Sep 25, 2023

LiMAx Breathing Mask Set B

912008761HUM100088

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Humedics GmbH
UDI-DI code: 09120087610099
Reference / catalog number: 201002MR

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Manufacturer information

Organization name: Humedics GmbH
SRN: DE-MF-000005094
Manufacturer status: Active

Critical warnings

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.

Market distribution

Primary placement in Germany; available across 3 countries total.

Country	On market since	Until
GermanyPrimary placement		Still on market
Austria		Still on market
Bulgaria		Still on market

Device identification

Trade name: LiMAx Breathing Mask Set B
UDI-DI code: 09120087610099
Basic UDI-DI: 912008761HUM100088
Reference / catalog number: 201002MR
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: https://www.humedics.de/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

R030199RESPIRATORY MASKS - OTHER

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

FLIP4.0B-MDD-FLIP4.0Z8On the market LiMAx breathing maskB-MDD-BreathingMaskKZOn the market LiMAx Breathing Mask Set A912008761HUM100088On the market LiMAx Measuring Device912008761HUM01408JOn the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.