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Smart CapnoLine O2 Long, Pediatric
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 989803160271
Identity
- Trade Name
- Smart CapnoLine O2 Long, Pediatric EUDAMEDSmart CapnoLine/Microstream FDA UDI
- Generic Name
- Nasal oxygen cannula, carbon-dioxide-sampling FDA UDI
- Device Name
- Microstream Advanced Capnography Lines EUDAMEDSmart CapnoLine O2 Long, Pediatric FDA UDI
- Model / Reference
- 989803160271 EUDAMEDSmart CapnoLine O2 Long, Pediatric FDA UDI
- Description
- Smart CapnoLine O2 Long, Pediatric FDA UDI
Identifiers
- Catalog Number
- 989803160271 FDA UDI
- Primary DI / UDI-DI
- 20884838071395 EUDAMEDFDA UDI
- Basic UDI-DI
- B-20884838071395 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
- Germany EUDAMED
- Commercial Distribution
- Not 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
Smart CapnoLine O2 Long, Pediatric 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-20884838071395 | 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 d5f8d374-2612-4b9a-a862-8cd966b3fba1 61 fields · synced Jun 18, 2026
- FDA UDI 308f20dd-3220-4fcc-822e-99ec0d179028 37 fields · synced May 30, 2026