989803145211

GUDID 00884838011700

Philips Medizin Systeme Böblingen GmbH

Electrocardiographic lead set, reusable
Primary Device ID00884838011700
NIH Device Record Key0b81bafa-47b5-4b8d-a391-204b04da18d6
Commercial Distribution StatusIn Commercial Distribution
Version Model Number989803145211
Catalog Number989803145211
Company DUNS314101143
Company NamePhilips Medizin Systeme Böblingen GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS100884838011700 [Primary]

FDA Product Code

IKDCABLE, ELECTRODE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-08-16
Device Publish Date2019-08-08

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.