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SO2 Optical Module

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref 989803151591

by Philips Medizin Systeme Böblingen GmbH

Identity

Trade Name
SO2 Optical Module EUDAMEDFDA UDI
Generic Name
Intravascular oxygen monitoring system FDA UDI
Device Name
SO2 Optical Module EUDAMED
SO2 Optical Module (Type P) for use with M1011A SO2 Module as for intravascular catheters such as scvO2 and svO2. See Instructions for Use for compatible catheters, catheters are not available from Philips. FDA UDI
Model / Reference
989803151591 EUDAMED
SO2 Optical Module FDA UDI
Description
SO2 Optical Module (Type P) for use with M1011A SO2 Module as for intravascular catheters such as scvO2 and svO2. See Instructions for Use for compatible catheters, catheters are not available from Philips. FDA UDI

Identifiers

Catalog Number
989803151591 FDA UDI
Primary DI / UDI-DI
00884838020849 EUDAMEDFDA UDI
Basic UDI-DI
B-00884838020849 EUDAMED
FDA Product Code
DSI FDA UDI
CBR FDA UDI
DRT FDA UDI
LKD FDA UDI
NHO FDA UDI
DXG FDA UDI
NHP FDA UDI
DRS FDA UDI
DSA FDA UDI
MLC FDA UDI
BZC FDA UDI
BZQ FDA UDI
DXN FDA UDI
DSF FDA UDI
KOI FDA UDI
KRC FDA UDI
CBQ FDA UDI
CBS FDA UDI
DSK FDA UDI
NHQ FDA UDI
MLD FDA UDI
CCK FDA UDI
CCL FDA UDI
DSJ FDA UDI
GWS FDA UDI
KLK FDA UDI
DPS FDA UDI
FLL FDA UDI
DRQ FDA UDI
ORT FDA UDI
KRB FDA UDI
MHX FDA UDI
DQA FDA UDI
DRJ FDA UDI
DRW FDA UDI
MSX FDA UDI
DSH FDA UDI
DRG FDA UDI
DSP FDA UDI
EMDN Code
Z12030280 VITAL SIGNS MONITORING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
GMDN Term
Intravascular oxygen monitoring system FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
870.1025 FDA UDI
868.1700 FDA UDI
870.2300 FDA UDI
868.2480 FDA UDI
868.1500 FDA UDI
870.1435 FDA UDI
870.2850 FDA UDI
870.2900 FDA UDI
870.2340 FDA UDI
868.1880 FDA UDI
868.2375 FDA UDI
870.1130 FDA UDI
870.2810 FDA UDI
868.2775 FDA UDI
870.2370 FDA UDI
868.1620 FDA UDI
870.1110 FDA UDI
868.1400 FDA UDI
868.1720 FDA UDI
870.1100 FDA UDI
882.1420 FDA UDI
868.2500 FDA UDI
880.2910 FDA UDI
870.2060 FDA UDI
882.1400 FDA UDI
870.1915 FDA UDI
870.2700 FDA UDI
870.2600 FDA UDI
870.2350 FDA UDI
870.2800 FDA UDI
870.2910 FDA UDI
870.3535 FDA UDI
Market of Registration
Austria EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Electrical-only medical device connection cable, reusable

SO2 Optical Module by Philips Medizin Systeme Böblingen GmbH — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrical-only medical device connection cable, reusable.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Philips Medizin Systeme Böblingen GmbH
EUDAMED SRN
DE-MF-000006026

Sources (2)

  • EUDAMED 902337ea-7769-425e-b4a0-6aaf9844741c 61 fields · synced Jul 17, 2026
  • FDA UDI bc7aea4f-c0a2-47ea-8f2e-680a2238ef7a 35 fields · synced May 30, 2026