DEVICE: SO2 Optical Module (00884838020849)

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Device Identifier (DI) Information
SO2 Optical Module
SO2 Optical Module
In Commercial Distribution
989803151591
Philips Medizin Systeme Böblingen GmbH
00884838020849
GS1

1
314101143 *Terms of Use
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.
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Device Characteristics
MR Unsafe
No
No
No
No
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
46299 Intravascular oxygen monitoring system
An assembly of devices used for the continuous in vivo measurement and display of the partial pressure of oxygen (pO2) in arterial blood. It typically includes a vascular catheter equipped with an oxygen transducer at its tip, a display, and programmable alarms. The system is used to determine ventilatory and metabolic status, particularly in patients with respiratory failure (e.g., from obstructive lung disease, severe asthma) or severe pulmonary hypertension.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DSI DETECTOR AND ALARM, ARRHYTHMIA
CBR Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
LKD Monitor, Carbon-Dioxide, Cutaneous
NHO Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)
DXG Computer, Diagnostic, Pre-Programmed, Single-Function
NHP Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
DRS Transducer, Blood-Pressure, Extravascular
DSA Cable, Transducer And Electrode, Patient, (Including Connector)
MLC Monitor, St Segment
BZC Calculator, Pulmonary Function Data
BZQ Monitor, Breathing Frequency
DXN System, Measurement, Blood-Pressure, Non-Invasive
DSF Recorder, Paper Chart
KOI Stimulator, Nerve, Peripheral, Electric
KRC Tester, Electrode, Surface, Electrocardiographic
CBQ Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
CBS Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
DSK Computer, Blood-Pressure
NHQ Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)
MLD Monitor, St Segment With Alarm
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
CCL Analyzer, Gas, Oxygen, Gaseous-Phase
DSJ Alarm, Blood-Pressure
GWS Analyzer, Spectrum, Electroencephalogram Signal
KLK Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
DPS Electrocardiograph
FLL Thermometer, Electronic, Clinical
DRQ Amplifier And Signal Conditioner, Transducer Signal
ORT Burst Suppression Detection Software For Electroencephalograph
KRB Probe, Thermodilution
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
DQA Oximeter
DRJ System, Signal Isolation
DRW Adaptor, Lead Switching, Electrocardiograph
MSX System, Network And Communication, Physiological Monitors
DSH Recorder, Magnetic Tape, Medical
DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
DSP System, Balloon, Intra-Aortic And Control
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Storage Environment Atmospheric Pressure: between 27 and 105 KiloPascal
Storage Environment Humidity: between 20 and 90 Percent (%) Relative Humidity
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
bc7aea4f-c0a2-47ea-8f2e-680a2238ef7a
May 05, 2023
6
December 18, 2018
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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