VentStar Helix heated (N) Plus
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- VentStar Helix beheizt (N) Plus EUDAMEDVentStar Helix heated (N) Plus FDA UDI
- Generic Name
- Ventilator breathing circuit, single-use FDA UDI
- Model / Reference
- MP02608 EUDAMEDFDA UDI308032XK19Z000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048675411758 EUDAMEDFDA UDI
- Basic UDI-DI
- 040486751308032XK19Z000EY EUDAMED
- 510(k) Number
- K222822 FDA UDI
- 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 IIb 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Ventilator breathing circuit, single-use
VentStar Helix heated (N) Plus by Drägerwerk AG & Co. KGaA — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Ventilator breathing circuit, single-use.
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Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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
- Drägerwerk AG & Co. KGaA
Sources (2)
- FDA UDI 5a0da3d4-cb8d-46b1-8ea7-06e1af2b76b2 33 fields · synced Jun 19, 2026
- EUDAMED 721b6d21-ba2e-4823-93b5-b9d2fb1195a1 61 fields · synced Jun 19, 2026