HHE19018WT0ECBCK

Organization name

Plastiflex Group NV

SRN

BE-MF-000008049

Manufacturer status

Active

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• CW010

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• CW014

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• CW011

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• CW007

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Primary placement in Belgium; available across 32 countries total.

Trade name

not provided

UDI-DI code

05404013004546

Basic UDI-DI

54040130000000000000169

Reference / catalog number

HHE19018WT0ECBCK

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 Rainout Control System consists of a heated tube and an independent power adaptor. The Hybernite heated breathing tube has standard cuffs on both the humidifier-end cuff and patient interface end cuff. As such, the Hybernite heated breathing tube can be connected to heated humidifiers that have standard male outlet connectors (ISO 5356‑1). Device under medical supervision. The Hybernite Rainout Control System is used to prevent condensation of humidified air delivered to patients requiring positive airway pressure or mask ventilation. The Hybernite Rainout Control System is indicated for use in the home or sleep-lab setting by a single adult patient.

Additional information URL

https://www.plastiflex.com/

Clinical sizes

• 183 MU10
• 19 MU50

• R02010401CPAP CIRCUITS

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

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