CARESCAPE ECG

GUDID 00840682124607

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Patient monitoring system module, multifunction
Primary Device ID00840682124607
NIH Device Record Key0b2fe26e-d40c-45d4-b8fd-339c46b9e852
Commercial Distribution StatusIn Commercial Distribution
Brand NameCARESCAPE ECG
Version Model NumberMKE101
Company DUNS784985108
Company NameGE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
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 Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)558-5120
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS100840682124607 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-14
Device Publish Date2020-04-06

Devices Manufactured by GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

00195278789846 - Mural Clinical Viewer2024-03-21 MD Mural Clinical Viewer 1.2 MEDICAL DEVICE
00840682139250 - Portrait CAU012023-10-13 Portrait Clinical Alarming Unit CAU01
00195278330413 - Portrait CVA012023-09-11 PORTRAIT CENTRAL STATION INSTALLATION SOFTWARE V1.0.2
00195278341129 - Portrait CSS012023-09-11 PORTRAIT CORE SERVICES INSTALLATION SOFTWARE V1.0.3
00195278577559 - Mural Clinical Viewer2023-07-24 MD Mural Clinical Viewer MEDICAL DEVICE
00195278571342 - ONE-CUF2023-05-24 ONE-CUF, SMALL ADULT, 1 TB BAYONET, 17 - 25 CM, SINGLE
00195278571359 - ONE-CUF2023-05-24 ONE-CUF, INFANT, 1 TB BAYONET, 08 - 13 CM SINGLE
00195278571366 - ONE-CUF2023-05-24 ONE-CUF, ADULT LONG, DINACLICK 5 , 23 - 33 CM, SINGLE

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.