Identity
- Trade Name
- CapnoTrak CO2/O2 Oral Nasal EUDAMEDCapnoTrak FDA UDI
- Generic Name
- Nasal oxygen cannula, carbon-dioxide-sampling FDA UDI
- Device Name
- Capnotrak Accessories EUDAMEDCapnoTrak CO2/O2 Oral Nasal Cannula FDA UDI
- Model / Reference
- 1105135 EUDAMEDFDA UDI
- Description
- CapnoTrak CO2/O2 Oral Nasal Cannula FDA UDI
Identifiers
- Catalog Number
- 1105135 FDA UDI
- Primary DI / UDI-DI
- 00884838044425 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM631T3 EUDAMED
- FDA Product Code
- CAT FDA UDI
- EMDN Code
- Z1203020485 GASEOUS EXCHANGE MONITORING INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Nasal oxygen cannula, carbon-dioxide-sampling FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5340 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 CO2/O2 Oral Nasal 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Respironics Novametrix, LLC
- EUDAMED SRN
- US-MF-000007951
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (2)
- EUDAMED 65f6d32a-7e91-460d-9176-2f3fd1dabf87 61 fields · synced Jun 19, 2026
- FDA UDI dc709fe5-1ce4-4e38-9c7a-c9d00a7e21d0 36 fields · synced May 30, 2026