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Pedi Nsl CO2 Line w/O2 LTerm

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 989803204591

by Philips Medical Systems

Identity

Trade Name
Pedi Nsl CO2 Line w/O2 LTerm EUDAMED
Microstream Advance Pediatric Nasal CO2 Filter Line FDA UDI
Generic Name
Nasal oxygen cannula, carbon-dioxide-sampling FDA UDI
Device Name
Microstream Advanced Capnography Lines EUDAMED
Pedi Nsl CO2 Line w/O2 LTerm FDA UDI
Model / Reference
989803204591 EUDAMED
Pedi Nsl CO2 Line w/O2 LTerm FDA UDI
Description
Pedi Nsl CO2 Line w/O2 LTerm FDA UDI

Identifiers

Catalog Number
989803204591 FDA UDI
Primary DI / UDI-DI
20884838093861 EUDAMEDFDA UDI
Basic UDI-DI
B-20884838093861 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 EUDAMED
Class 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
MRI Safety
MR Unsafe FDA UDI

Pedi 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

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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 3e2ab295-fdbf-4578-9bcf-b3a31c0fb382 61 fields · synced Jul 13, 2026
  • FDA UDI 616f3f53-58f3-4937-8d20-b07c1c73bd2d 37 fields · synced May 30, 2026