HEN19038BT1SSWGK

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 Germany; available across 10 countries total.

Trade name

not provided

UDI-DI code

05404013003600

Basic UDI-DI

5404013000000000000026B

Reference / catalog number

HEN19038BT1SSWGK

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 Hybernite RT 1000 (Dual limb) is intended for use with the Fischer & Paykel MR850 respiratory humidifier and a ventilator and accessories with conical ISO connectors (ISO 5356-1). The product consists of 3 tubes packaged together in a plastic bag. Besides the heated inspiratory and heated expiratory tube, the package also contains a non-heated connection tube to connect the ventilator to the humidifier.

Additional information URL

https://www.plastiflex.com/

Clinical sizes

• 380 MU10
• 19 MU50
• Adult

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

• R020107THERMOREGULATED BREATHING CIRCUITS