MR Patient Care Wide ECG 3.0 Cable IEC 989803193751

GUDID 00884838121157

ECG lead cable designed for use with 3rd-generation wireless ECG module and CV Quadtrodes (IEC coded leads.)

Philips Medizin Systeme Böblingen GmbH

Electrocardiographic lead set, reusable
Primary Device ID00884838121157
NIH Device Record Keya4aa73ce-b6e8-4b21-9a20-9e7e4b4dc649
Commercial Distribution StatusIn Commercial Distribution
Brand NameMR Patient Care Wide ECG 3.0 Cable IEC
Version Model NumberWide ECG 3.0 Cable IEC
Catalog Number989803193751
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 Batchtrue
Serial Numberfalse
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 -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 1020 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 1020 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 1020 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 1020 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 1020 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 1020 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 1020 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 1020 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 1020 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 1020 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 1020 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 1020 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 1020 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 1020 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 1020 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 1020 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 570 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 429 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 1020 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100884838121157 [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 Date2025-05-28
Device Publish Date2025-05-20

Devices Manufactured by Philips Medizin Systeme Böblingen GmbH

00884838117198 - patient lead wire2026-01-26 Complete Lead Set for PageWriter TC Series Cardiographs, AAMI Color Coded. Consisting of 2 arm leads (39"(1m)), 2 leg leads (41"
00884838117204 - patient lead wire2026-01-26 Complete Lead Set for PageWriter TC Series Cardiographs, IEC Color Coded. Consisting of 2 arm leads (39"(1m)), 2 leg leads (41"
00884838117211 - patient lead wire2026-01-26 Long complete lead set for PageWriter TC Series Cardiographs, AAMI color coded. Consisting of 2 long arm leads (54" (1,37m)), 2
00884838117228 - patient lead wire2026-01-26 Long complete lead set for PageWriter TC Series Cardiographs, IEC color coded. Consisting of 2 long arm leads (54" (1,37m)), 2 l
00884838086678 - Masimo Sedline Module2026-01-23 Masimo SedLine Plug-in Module for IntelliVue Patient Monitors to connect the Masimo SedLine Measurement Device (989803203051)
00884838117259 - patient lead wire2026-01-23 Limb lead set for PageWriter TC Series Cardiographs, AAMI and IEC color coded. Consisting of 2 arm leads (39",99cm), 2 leg leads
00884838117266 - patient lead wire2026-01-23 Long Limb lead set for PageWriter TC Series Cardiographs, AAMI and IEC color coded. Consisting of 2 long arm leads (54",1,37m),
00884838117235 - patient lead wire2025-12-23 Chest lead Set for PageWriter TC Series Cardiographs AAMI and IEC color coded, consisting of one 1 in 3 (Trident) Lead ( 28" (70

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.