PHILIPS External Device Interface Module 862292

GUDID 00884838021099

Philips Medizin Systeme Böblingen GmbH

Patient monitoring system module, interfacing
Primary Device ID00884838021099
NIH Device Record Key9cc96c98-0155-4686-b3e9-aa9cd829b7cb
Commercial Distribution StatusIn Commercial Distribution
Brand NamePHILIPS External Device Interface Module
Version Model Number862292
Catalog Number862292
Company DUNS314101143
Company NamePhilips Medizin Systeme Böblingen GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100884838021099 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MHXMONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-11-01

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.