GUDID 00840682119078

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Blood pressure cuff, reusable
Primary Device ID00840682119078
NIH Device Record Key98c1b783-b855-401e-b3c0-ccf2a9f5fc1e
Commercial Distribution StatusIn Commercial Distribution
Version Model Number002281
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 Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100840682119078 [Primary]
GS100840682120593 [Package]
Package: [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXQblood pressure cuff

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-07-22
Device Publish Date2016-06-17

Devices Manufactured by GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

00195278726391 - MURAL PERINATAL SURVEILLANCE2024-06-10 MD MURAL PERINATAL SURVEILLANCE 2.2 MEDICAL DEVICE
00195278561312 - Portrait VSM2024-05-13 Portrait VSM ATO MODEL
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

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