T2100

GUDID 00840682106023

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Stress test treadmill
Primary Device ID00840682106023
NIH Device Record Key86e3aaa6-7c0d-49d0-b640-2bc44308b873
Commercial Distribution Discontinuation2017-07-25
Commercial Distribution StatusNot in Commercial Distribution
Brand NameT2100
Version Model NumberTreadmill
Company DUNS784985108
Company NameGE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
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 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
GS100840682106023 [Primary]

FDA Product Code

IOLTREADMILL, POWERED

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-07-25

Devices Manufactured by GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

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00195278656681 - Portrait CVAXB2024-05-08 Portrait Central Viewer Application Installer v1.1.0
00195278659446 - Portrait CSSXB2024-05-08 PORTRAIT CORE SERVICES INSTALLATION SOFTWARE V1.1.0
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

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