Pediatric/Adult Combined CO2/Flow Sensor
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- Pediatric/Adult Combined CO2/Flow Sensor EUDAMEDFlow Sensor FDA UDI
- Generic Name
- Breathing circuit gas-sampling/monitoring set FDA UDI
- Device Name
- Flow Sensor EUDAMEDPediatric / Adult Combined CO2/Flow Sensor Series 3 FDA UDI
- Model / Reference
- 6719-00 EUDAMEDFDA UDI
- Description
- Pediatric / Adult Combined CO2/Flow Sensor Series 3 FDA UDI
Identifiers
- Catalog Number
- 6719-00 FDA UDI
- Primary DI / UDI-DI
- 00884838014114 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM626TA EUDAMED
- FDA Product Code
- BXP FDA UDI
- EMDN Code
- Z12150185 SPIROMETRY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Breathing circuit gas-sampling/monitoring set FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.2885 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Pulmonary function testing filter/mouthpiece
Pediatric/Adult Combined CO2/Flow Sensor by Respironics Novametrix, LLC — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0884838BM626TA | 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 62a41b2a-06e1-447a-9ee8-9373a0fb929a 61 fields · synced Jun 18, 2026
- FDA UDI 29620cff-6862-4abe-a252-270c8e9e73c0 35 fields · synced May 30, 2026