Identity
- Trade Name
- LoFlo Sidestream CO2 Module EUDAMEDLoFlo Sidestream FDA UDI
- Generic Name
- Patient monitoring system module, carbon dioxide FDA UDI
- Device Name
- Capnostat 5 LFLO EUDAMEDRespironics LoFlo Sidestream CO2 Module FDA UDI
- Model / Reference
- 1050797 EUDAMEDFDA UDI
- Description
- Respironics LoFlo Sidestream CO2 Module FDA UDI
Identifiers
- Catalog Number
- 1050797 FDA UDI
- Primary DI / UDI-DI
- 00884838082281 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM632T5 EUDAMED
- Direct Marketing DI
- 00884838082281 EUDAMED
- FDA Product Code
- CCK FDA UDI
- EMDN Code
- Z1203020499 GASEOUS EXCHANGE MONITORING INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Patient monitoring system module, carbon dioxide FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.1400 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
LoFlo Sidestream CO2 Module 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 | 0884838BM632T5 | 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 2b057ffe-577a-4f6f-be43-bc85623c2284 61 fields · synced Jun 18, 2026
- FDA UDI 6e04efd7-0f77-425b-a8b0-b3699724c46d 36 fields · synced May 30, 2026