HPE19018WT0019GI

Organization name

Plastiflex Group NV

SRN

BE-MF-000008049

Manufacturer status

Active

Certificate health across this manufacturer's portfolio.

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

• CW014

  EUDAMED did not publish a description for this code.
• 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

05404013003563

Basic UDI-DI

54040130000000000000169

Reference / catalog number

HPE19018WT0019GI

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

The prismaHYBERNITE Heated Breathing Tube is intended for use with the WM100TD Positive Airway Pressure (PAP) device. The prismaHYBERNITE heated tube helps to prevent moisture condensation in the breathing tube of adult patients requiring continuous positive airways pressure or mask ventilation. The prismaHYBERNITE can be used in the sleep lab and in the home. It can also be used in conjunction with supplemental Oxygen. The prismaHYBERNITE is intended for adult patients only. Device 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.

• R02010401CPAP CIRCUITS