HWE19018GT0051GI

Organization name

Plastiflex Group NV

SRN

BE-MF-000008049

Manufacturer status

Active

Certificate health across this manufacturer's portfolio.

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

• CW011

  EUDAMED did not publish a description for this code.
• CW010

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.

Primary placement in Belgium; available across 32 countries total.

Trade name

not provided

UDI-DI code

05404013004676

Basic UDI-DI

54040130000000000000067

Reference / catalog number

HWE19018GT0051GI

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

Non-heated respiratory tubes intended for use with respiratory therapy devices and humidifiers with conical ISO connectors (ISO 5356-1) for the treatment of sleep apnea or home ventilation. These tubes can also be used as a non-heated part of a ventilation circuit. The tubes are intended to transport breathing gases (with or without supplemental oxygen) from the flow generator to the patient and back. The tubes are indicated for non-invasive and invasive respiratory therapy in the home, hospital or sleep-lab setting by a single patient. These devices are to be used under medical supervision.

Additional information URL

https://www.plastiflex.com/

Clinical sizes

• 183 MU10
• 19 MU50

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

• R9080RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES