VentStar Resuscitaire CEU
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- VentStar Resuscitaire EUDAMEDVentStar Resuscitaire CEU FDA UDI
- Generic Name
- Ventilator breathing circuit, single-use FDA UDI
- Model / Reference
- 422341 EUDAMEDMP00311 EUDAMEDMP00310 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04048675422341 EUDAMED04048675026600 FDA UDI
- Basic UDI-DI
- B-04048675422341 EUDAMED
- 510(k) Number
- K092029 FDA UDI
- FDA Product Code
- BYE FDA UDI
- EMDN Code
- R020199 BREATHING CIRCUITS AND KITS - OTHER EUDAMED
- GMDN Term
- Ventilator breathing circuit, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5965 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 Resuscitaire CEU by Drägerwerk AG & Co. KGaA — Class II — MDD, 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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Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | 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 4d8d43af-e63b-4fda-b3c2-5c6a388f933f 34 fields · synced Jul 24, 2026
- EUDAMED a3a45b67-f70e-4409-bfab-0d57fab48c8f 61 fields · synced Jul 24, 2026