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Smart CapnoLine H O2 Pediatric Long
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 989803177981
Identity
- Trade Name
- Smart CapnoLine H O2 Pediatric Long EUDAMEDSmart CapnoLine / Microstream FDA UDI
- Generic Name
- Nasal oxygen cannula, carbon-dioxide-sampling FDA UDI
- Device Name
- Microstream Advanced Capnography Lines EUDAMEDSmart CapnoLine: Oral/Nasal, CO2/O2, Pediatric, long term, 4m FDA UDI
- Model / Reference
- 989803177981 EUDAMEDSmart CapnoLine H O2 Pediatric Long FDA UDI
- Description
- Smart CapnoLine: Oral/Nasal, CO2/O2, Pediatric, long term, 4m FDA UDI
Identifiers
- Catalog Number
- 989803177981 FDA UDI
- Primary DI / UDI-DI
- 20884838071081 EUDAMEDFDA UDI
- Basic UDI-DI
- B-20884838071081 EUDAMED
- FDA Product Code
- CCK FDA UDI
- EMDN Code
- Z1203020299 MULTI–PARAMETER MONITORS - OTHER EUDAMED
- GMDN Term
- Nasal oxygen cannula, carbon-dioxide-sampling 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
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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Smart CapnoLine H O2 Pediatric Long by Philips Medical Systems — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-20884838071081 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Philips Medical Systems
- EUDAMED SRN
- US-MF-000002321
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (2)
- EUDAMED 66f0b114-7508-4ed2-ba49-d480b5825368 61 fields · synced Jun 19, 2026
- FDA UDI 417a9505-b6a3-4107-84d5-39585796828f 36 fields · synced May 30, 2026