GUDID 00840682123662

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Single-patient intensive/general healthcare physiologic monitoring system General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor
Primary Device ID00840682123662
NIH Device Record Key16b49c07-71c6-4488-a892-43e364218d4f
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberD4 MAS GOLDSEAL
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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840682123662 [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 Number4
Public Version Date2020-02-06
Device Publish Date2017-04-11

Devices Manufactured by GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

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00195278577559 - Mural Clinical Viewer2023-07-24 MD Mural Clinical Viewer MEDICAL DEVICE
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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
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