Identity
- Trade Name
- CapnoTrak Airway Adapter Set EUDAMEDCapnoTrak FDA UDI
- Generic Name
- Gas-sampling/monitoring respiratory tubing, single-use FDA UDI
- Device Name
- Capnotrak Accessories EUDAMEDCapnoTrak Airway Adapter Set FDA UDI
- Model / Reference
- 1103415 EUDAMEDFDA UDI
- Description
- CapnoTrak Airway Adapter Set FDA UDI
Identifiers
- Catalog Number
- 1103415 FDA UDI
- Primary DI / UDI-DI
- 00884838040076 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM631T3 EUDAMED
- FDA Product Code
- BZA FDA UDI
- EMDN Code
- Z1203020485 GASEOUS EXCHANGE MONITORING INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Gas-sampling/monitoring respiratory tubing, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5810 FDA UDI
- Market of Registration
- Austria 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
CapnoTrak Airway Adapter Set by Respironics Novametrix, LLC — Class IIa — 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 | 0884838BM631T3 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Respironics Novametrix, LLC
- EUDAMED SRN
- US-MF-000007951
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (2)
- EUDAMED 0ec6280c-1d49-4b64-a63a-096278cb8f55 61 fields · synced Jun 20, 2026
- FDA UDI 146b030a-dbe0-496c-b7ad-b57077439234 36 fields · synced May 29, 2026