MR Patient Care SpO2 Sensor 989803161991

GUDID 00884838111370

Fiber Optic SpO2 Sensor for use with Wireless SpO2 3.0 Module (Networks 1-5) 989803192771 and SpO2 Clips and Grips accessories

Philips Medizin Systeme Böblingen GmbH

Pulse oximeter probe, reusable
Primary Device ID00884838111370
NIH Device Record Keyd8393400-34a7-44ea-b0e5-bcb1b5fecb49
Commercial Distribution StatusIn Commercial Distribution
Brand NameMR Patient Care SpO2 Sensor
Version Model NumberSpO2 Sensor
Catalog Number989803161991
Company DUNS314101143
Company NamePhilips Medizin Systeme Böblingen GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100884838111370 [Primary]

FDA Product Code

MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-09
Device Publish Date2025-05-30

Devices Manufactured by Philips Medizin Systeme Böblingen GmbH

00884838111370 - MR Patient Care SpO2 Sensor2025-06-09Fiber Optic SpO2 Sensor for use with Wireless SpO2 3.0 Module (Networks 1-5) 989803192771 and SpO2 Clips and Grips accessories
00884838111370 - MR Patient Care SpO2 Sensor2025-06-09 Fiber Optic SpO2 Sensor for use with Wireless SpO2 3.0 Module (Networks 1-5) 989803192771 and SpO2 Clips and Grips accessories
00884838111479 - MR Patient Care Temperature Sensor (Esophageal / Rectal / Axillary, Direct Mode)2025-06-09 Temperature sensor for Expression MRI patient monitors, capable of surface measurement or, with applied FlexTEMP Jacket, esophog
00884838111400 - MR Patient Care Temperature Sensor Jacket2025-06-09 Disposable Flex Temp Jacket is designed for use with the FlexTEMP System, Sensor. The FlexTEMP Jacket must be used with the Flex
00884838120563 - MR Patient Care Kit, Sample, Agents, 31602025-05-29 KIT,SAMPLE,AGENTS,3160
00884838117839 - MR Patient Care Single Patch ECG Electrodes (25)2025-05-29 QUADTRODE MRI ECG PAD,25/BOX
00884838117846 - MR Patient Care Multiple Patch ECG Electrodes (25)2025-05-29 ELECTRODE, MRI ECG, QUADTRODE CV, 25/BOX
00884838117853 - MR Patient Care Neonatal ECG Electrodes (25)2025-05-29 ELECTRODE, NEONATE MRI ECG, QUADTRODE CV, 25/BOX
00884838120532 - MR Patient Care Short Wide ECG 2.0 Cable AAMI2025-05-28 CAB,4 LD,CV MRI ECG,3160

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