← Back to catalogue
Pedi Orl/Nsl CO2 Line w/O2 LTerm
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 989803204401
Identity
- Trade Name
- Pedi Orl/Nsl CO2 Line w/O2 LTerm EUDAMEDMicrostream Advance Pediatric Oral-Nasal CO2 Filter Line FDA UDI
- Generic Name
- Nasal oxygen cannula, carbon-dioxide-sampling FDA UDI
- Device Name
- Microstream Advanced Capnography Lines EUDAMEDPediatric Oral-Nasal CO2 Filter Line with O2 Tubing, Extended Duration FDA UDI
- Model / Reference
- 989803204401 EUDAMEDPedi Orl/Nsl CO2 Line w/O2 LTerm FDA UDI
- Description
- Pediatric Oral-Nasal CO2 Filter Line with O2 Tubing, Extended Duration FDA UDI
Identifiers
- Catalog Number
- 989803204401 FDA UDI
- Primary DI / UDI-DI
- 20884838091911 EUDAMEDFDA UDI
- Basic UDI-DI
- B-20884838091911 EUDAMED
- 510(k) Number
- K181624 FDA UDI
- FDA Product Code
- CCK FDA UDI
- EMDN Code
- Z1203020202 TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Pedi Orl/Nsl CO2 Line w/O2 LTerm 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-20884838091911 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Philips Medical Systems
- EUDAMED SRN
- US-MF-000002321
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (2)
- EUDAMED b52185b5-74c0-49cf-95bb-fe2ad409b5f0 61 fields · synced Jun 18, 2026
- FDA UDI 0ca2162a-5b58-4669-8017-40be7a647209 37 fields · synced May 30, 2026