patient lead wire 989803151671

GUDID 00884838117235

Chest lead Set for PageWriter TC Series Cardiographs AAMI and IEC color coded, consisting of one 1 in 3 (Trident) Lead ( 28" (70 cm)), 12*2 colored rings, 3 brown base rings, 3 white base rings (both AAMI and IEC), 3 banana post adapters, 4 Trident Yoke lead description lables (V1-V3, V4-V6, C1-C3, C4-C6) and instruction for use. The Trident lead comes assembled with the lead separator.

Philips Medizin Systeme Böblingen GmbH

Electrocardiographic lead set, reusable
Primary Device ID00884838117235
NIH Device Record Keyf98f9a1b-4618-4e0c-8ce2-7019039fdce7
Commercial Distribution StatusIn Commercial Distribution
Brand Namepatient lead wire
Version Model NumberChest Lead Set, AAMI/IEC
Catalog Number989803151671
Company DUNS314101143
Company NamePhilips Medizin Systeme Böblingen GmbH
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 101.4 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 101.4 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 101.4 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 101.4 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 101.4 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 101.4 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 101.4 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 101.4 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 101.4 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 101.4 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100884838117235 [Primary]

FDA Product Code

DPSElectrocardiograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-23
Device Publish Date2025-12-15

On-Brand Devices [patient lead wire]

00884838117242Long Chest lead Set for PageWriter TC Series Cardiographs, AAMI and IEC color coded. Consisting
00884838117235Chest lead Set for PageWriter TC Series Cardiographs AAMI and IEC color coded, consisting of one
00884838117266Long Limb lead set for PageWriter TC Series Cardiographs, AAMI and IEC color coded. Consisting o
00884838117259Limb lead set for PageWriter TC Series Cardiographs, AAMI and IEC color coded. Consisting of 2 a
00884838117228Long complete lead set for PageWriter TC Series Cardiographs, IEC color coded. Consisting of 2 l
00884838117211Long complete lead set for PageWriter TC Series Cardiographs, AAMI color coded. Consisting of 2
00884838117204Complete Lead Set for PageWriter TC Series Cardiographs, IEC Color Coded. Consisting of 2 arm le
00884838117198Complete Lead Set for PageWriter TC Series Cardiographs, AAMI Color Coded. Consisting of 2 arm l
00884838117341PW TC20 Long 10-Lead Patient Cable AHA
00884838117334PW TC20 Long 10-Lead Patient Cable IEC
00884838117327PW TC20 10-Lead Patient Cable AHA
00884838117310PW TC20 10-Lead Patient Cable IEC
00884838117303Long Upgrade Kit 12-15/16 leads IEC color coded for PageWriter TC70. Consisting of 4 additional
00884838117297Long Upgrade Kit 12-15/16 leads AAMI color coded for PageWriter TC70. Consisting of 4 additional
00884838117280Upgrade Kit 12-15/16 leads IECI color coded for PageWriter TC 70. Consisting of 4 additional lea
00884838117273Upgrade Kit 12-15/16 leads AAMI color coded for PageWriter TC 70. Consisting of 4 additional lea
00884838117358Std 10-lead Patient Cable IEC
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