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Hybernite RT
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref HPN12016BT1FTWBBModel The Hybernite RT breathing tubes are combined in breathing sets in a single limb version (only inspiratory tube) or a dual limb (inspiratory and expiratory tube) version. Products are available in 3 diameters and in different packaging combinations
Identity
- Trade Name
- Hybernite RT 12 ins EUDAMEDHybernite RT FDA UDI
- Generic Name
- Ventilator breathing circuit, single-use FDA UDI
- Device Name
- Hybernite RT EUDAMED
- Model / Reference
- The Hybernite RT breathing tubes are combined in breathing sets in a single limb version (only inspiratory tube) or a dual limb (inspiratory and expiratory tube) version. Products are available in 3 diameters and in different packaging combinations EUDAMEDHPN12016BT1FTWBB EUDAMEDHybernite RT 12 ins FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05404013000210 EUDAMEDFDA UDI
- Basic UDI-DI
- 5404013000000000000026B EUDAMED
- FDA Product Code
- BZE FDA UDI
- EMDN Code
- R020107 THERMOREGULATED BREATHING CIRCUITS EUDAMED
- GMDN Term
- Ventilator breathing circuit, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5270 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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, single-use
Hybernite RT by Plastiflex Group NV — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 aeed515d-7f98-4950-ace3-72b8d238736b 32 fields · synced Jun 19, 2026
- EUDAMED 085a9d3e-5f82-43e2-ae6e-e16b3ec18158 61 fields · synced Jun 14, 2026