HUE19018GT0SSGGK

Organization name

Plastiflex Group NV

SRN

BE-MF-000008049

Manufacturer status

Active

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

• CW010

  1. Please keep this user’s manual for future reference. 2. Always touch the tube at the cuffs, when connecting or disconnecting the therapy device, humidifier and patient interface. 3. Do not pull the tube when disengaging the tube from the humidifier. 4. The tube must not be heated (>60° C / >140° F) or sterilized. 5. Do not place the tube against any heat source. 6. Do not use the tube on multiple patients. 7. Do not disassemble the tube or damage it. 8. Do not insert or drop any object in the openings of the tube as it can damage the tube. 9. Do not place materials or objects on the tube as it can damage the tube. 10. If the tube is damaged (holes, creases, tears, etc.) or no longer functional, do not try to repair it. Replace the tube immediately. 11. The tube should not be used for longer than the indicated life cycle to avoid contamination; the tube should be replaced once this period is over. 12. In case of using the tube with a pressure sensor line always use the 2 tube plugs to close the ends of the pressure sensor line to avoid water ingress which can cause a false measurement of the pressure or a reduced reaction of the pressure regulator. Both have a negative influence on optimal treatment. 13. For tubes intended for invasive and non-invasive respiratory therapy regularly check the breathing circuit for condensate and empty if necessary, since, if too much condensate accumulates, a partial or complete blockage of the circuit can occur.

Primary placement in Belgium; available across 32 countries total.

Trade name

not provided

UDI-DI code

05404013001576

Basic UDI-DI

54040130000000000000067

Reference / catalog number

HUE19018GT0SSGGK

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

• 19 MU50
• 183 MU10

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

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