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Ventstar Coax
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref MP03373Model 2080456K19Z000
Identity
- Trade Name
- Ventstar Coax EUDAMEDFDA UDI
- Generic Name
- Ventilator breathing circuit, single-use FDA UDI
- Model / Reference
- MP03373 EUDAMEDFDA UDI2080456K19Z000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048675545552 EUDAMEDFDA UDI
- Basic UDI-DI
- 0404867512080456K19Z000UZ EUDAMED
- FDA Product Code
- BZO FDA UDICAI FDA UDI
- EMDN Code
- R020102 COAXIAL BREATHING CIRCUITS EUDAMED
- GMDN Term
- Ventilator breathing circuit, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5975 FDA UDI868.5240 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ventilator breathing circuit, single-use
Ventstar Coax by Drägerwerk AG & Co. KGaA — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Ventilator breathing circuit, single-use.
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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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Drägerwerk AG & Co. KGaA
Sources (2)
- FDA UDI 9bbc14db-0004-46a7-9747-2ff39e605fea 33 fields · synced Jul 28, 2026
- EUDAMED a146650e-eabc-487e-a2be-d5e3525dd3b0 61 fields · synced Jul 28, 2026