Identity
- Trade Name
- CapnoTrak Water Filter Assembly EUDAMEDCapnoTrak FDA UDI
- Generic Name
- Gas dehumidification tubing set, reusable FDA UDI
- Device Name
- CapnoTrak Reusable EUDAMEDCapnoTrak Water Filter Assembly FDA UDI
- Model / Reference
- 1103416 EUDAMEDFDA UDI
- Description
- CapnoTrak Water Filter Assembly FDA UDI
Identifiers
- Catalog Number
- 1103416 FDA UDI
- Primary DI / UDI-DI
- 00884838056329 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM737TL EUDAMED
- FDA Product Code
- CAT FDA UDI
- EMDN Code
- Z1203020485 GASEOUS EXCHANGE MONITORING INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Gas dehumidification tubing set, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA 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
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
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 Water Filter Assembly by Respironics Novametrix, LLC — Class I — 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 | 0884838BM737TL | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 9534caa9-a529-4694-a0e0-39c0d8d21af7 61 fields · synced Jun 19, 2026
- FDA UDI 2e2c7dd9-41a5-4fc5-89e0-b6c2abf00ec7 36 fields · synced May 30, 2026