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Hybernite
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref HRN19018WT0ECWGCModel Hybernite : Tube models consist of different lengths, diameter, rib colour, connections within the cuff
Identity
- Trade Name
- Hybernite HBT EUDAMEDHybernite FDA UDI
- Generic Name
- Ventilator breathing circuit, reusable FDA UDI
- Device Name
- Active non implantable respiratory devices. EUDAMED
- Model / Reference
- Hybernite : Tube models consist of different lengths, diameter, rib colour, connections within the cuff EUDAMEDHRN19018WT0ECWGC EUDAMEDHybernite HBT White FDA UDI
Identifiers
- Catalog Number
- HRN19018WT0ECWGC FDA UDI
- Primary DI / UDI-DI
- 05404013000807 EUDAMEDFDA UDI
- Basic UDI-DI
- 54040130000000000000169 EUDAMED
- FDA Product Code
- BZE FDA UDI
- EMDN Code
- R02010401 CPAP CIRCUITS EUDAMED
- GMDN Term
- Ventilator breathing circuit, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5270 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ventilator breathing circuit, reusable
Hybernite by Plastiflex Group NV — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Ventilator breathing circuit, reusable.
- KC 042-B - 22mm ID Reusable Ventilator Tubing — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class I
- KC 004-GG - 22mm ID Reusable Ventilator Tubing — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class I
- KC 042-3 22mm ID Ventilator Tubing with Integral Cuffs — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class I
- KC 048-N - 10mm ID Reusable Ventilator Tubing — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class I
- KC 036-N - 10mm ID Reusable Ventilator Tubing — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class I
- KC 018-P - 15mm ID Reusable Ventilator Tubing — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class I
- RESMED — RESMED PTY LTD · Class I
- Vivo Series — Breas Medical AB · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Plastiflex Group NV
Sources (2)
- FDA UDI b975899d-4df1-4d7f-a755-c33f91ccb27f 33 fields · synced Jul 10, 2026
- EUDAMED 358b4aae-7e8c-4940-bc24-a55b8fd33d56 61 fields · synced Jul 10, 2026