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Smart CapnoLine O2 Plus Long, Adult
EUDAMEDFDA UDIClass I (EU MDR)
Ref 989803160281
Identity
- Trade Name
- Smart CapnoLine O2 Plus Long, Adult EUDAMEDSmart CapnoLine/Microstream FDA UDI
- Generic Name
- Gas-sampling/monitoring respiratory tubing, single-use FDA UDI
- Device Name
- Microstream Advanced EUDAMEDSmart CapnoLine O2 Plus Long, Adult FDA UDI
- Model / Reference
- 989803160281 EUDAMEDSmart CapnoLine O2 Plus Long, Adult FDA UDI
- Description
- Smart CapnoLine O2 Plus Long, Adult FDA UDI
Identifiers
- Catalog Number
- 989803160281 FDA UDI
- Primary DI / UDI-DI
- 20884838071401 EUDAMEDFDA UDI
- Basic UDI-DI
- B-20884838071401 EUDAMED
- FDA Product Code
- MHX FDA UDI
- EMDN Code
- Z1203020299 MULTI–PARAMETER MONITORS - OTHER EUDAMED
- GMDN Term
- Gas-sampling/monitoring respiratory tubing, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1025 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 Plus Long, Adult by Philips Medical Systems — Class I — 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-20884838071401 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 1482953f-5856-4594-bfad-44cdfe67d4c2 61 fields · synced Jun 19, 2026
- FDA UDI 989157bd-10ff-476d-ba77-97b43eba59d4 37 fields · synced May 30, 2026