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Hybernite RT
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref HFN19022BT1STWGLModel 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 114 EUDAMEDHybernite RT FDA UDI
- Generic Name
- Ventilator breathing circuit, single-use FDA UDI
- Device Name
- Hybernite RT EUDAMEDHybernite RT 114 FDA UDI
- 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 EUDAMEDHFN19022BT1STWGL EUDAMEDRT 114 FDA UDI
- Description
- Hybernite RT 114 FDA UDI
Identifiers
- Catalog Number
- HFN19022BT1STWGL FDA UDI
- Primary DI / UDI-DI
- 05404013003730 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 13b8cad5-3535-4140-ad3c-d15c159c06c9 34 fields · synced Jul 9, 2026
- EUDAMED e9ac8be5-fa61-4f1e-ab0b-71b97b575918 61 fields · synced Jul 9, 2026