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Organization name
UDI-DI code
Reference / catalog number

Medicare CPR Pocket Mask — Class I MDR by Fleming Medical

MD Atlas
Fleming Medical

EUDAMED last updated this device on Mar 11, 2026

Medicare CPR Pocket Mask

5099390PMaskDX

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Fleming Medical
UDI-DI code: 05099390416237
Reference / catalog number: MD1889

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Manufacturer information

Organization name: Fleming Medical
SRN: IE-MF-000044303
Manufacturer status: Active

Critical warnings

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

CW011
The product can be used only once, should be used immediately after opening the package and destroyed afterwards; if it is reused，the users or patients can be infected, patients have adverse reactions such as irritation and sensitization.

Market distribution

Primary placement in Ireland; available across 1 country total.

Placed on the market in Ireland; per-country availability dates not published.

Device identification

Trade name: Medicare CPR Pocket Mask
UDI-DI code: 05099390416237
Basic UDI-DI: 5099390PMaskDX
Reference / catalog number: MD1889
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: The CPR shield consists of a PVC mask that includes the mask itself, a one-way valve, elastic brand , gloves and wipes. It is primarily used a administer artificial respiration to a patient, helping maintain normal breathing for a short period until the patient regains consciousness. This device serves as a simple tool for artificial ventilation.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

R03010199VENTILATION 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

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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.