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Diagnostics Package Capnography Mainstream
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 301.114.000
Identity
- Trade Name
- Vyaire FDA UDI
- Generic Name
- Patient monitoring system module, carbon dioxide FDA UDI
- Device Name
- DIAGNOSTICS PACKAGE CAPNOGRAPHY MAINSTREAM EUDAMEDDiagnostic Package Capnography Mainstream FDA UDI
- Model / Reference
- 301.114.000 EUDAMEDFDA UDI
- Description
- Diagnostic Package Capnography Mainstream FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10190752188853 EUDAMEDFDA UDI
- Basic UDI-DI
- 0190752PRMET0112BL4 EUDAMED
- 510(k) Number
- K183364 FDA UDI
- FDA Product Code
- CBK FDA UDI
- EMDN Code
- Z1203010599 PULMONARY VENTILATORS FOR HOSPITAL USE - OTHER EUDAMED
- GMDN Term
- Patient monitoring system module, carbon dioxide FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5895 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Diagnostics Package Capnography Mainstream by Vyaire Medical, Inc. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0190752PRMET0112BL4 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Vyaire Medical, Inc.
- EUDAMED SRN
- US-MF-000008254
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 06a3c3d1-40ab-42e6-bd55-3b0963d2bf8d 61 fields · synced Jul 28, 2026
- FDA UDI aeaccea9-530a-4280-91d0-c55bc461fad8 36 fields · synced May 30, 2026