989803105661

GUDID 00884838011908

Philips Medizin Systeme Böblingen GmbH

Electrode conductive medium
Primary Device ID00884838011908
NIH Device Record Key9876282d-df64-44b7-a7fb-dc61d4188e6c
Commercial Distribution StatusIn Commercial Distribution
Version Model Number989803105661
Catalog Number989803105661
Company DUNS314101143
Company NamePhilips Medizin Systeme Böblingen GmbH
Device Count1
DM Exemptfalse
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 Datetrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100884838011908 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWQFull-montage Standard Electroencephalograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-10-22
Device Publish Date2016-12-13

Devices Manufactured by Philips Medizin Systeme Böblingen GmbH

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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
00884838120549 - MR Patient Care Short Standard ECG 2.0 Cable AAMI2025-05-28 CAB,4 LD,MRI ECG,3160
00884838120693 - MR Patient Care Long Wide ECG 2.0 Cable AAMI2025-05-28 ECG Leadwire Set designed for use with the Expression MRI Patient Monitor when utlizing the system's Advanced ECG Gradient Filte
00884838120730 - MR Patient Care Long Extra Wide ECG 2.0 Cable AAMI2025-05-28 Advanced Apps ECG Cable for wireless ECG modules

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