Corsium Crew Application

GUDID 05060472441348

REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED

Transportable physiologic monitoring system
Primary Device ID05060472441348
NIH Device Record Keyd156ad8a-c459-48b6-be70-f3de8f158ba1
Commercial Distribution StatusIn Commercial Distribution
Brand NameCorsium Crew Application
Version Model Number01-2508
Company DUNS896707940
Company NameREMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
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 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
GS105060472441348 [Primary]

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 Date2018-11-26
Device Publish Date2018-10-25

Devices Manufactured by REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED

05060472442901 - Tempus Pro2022-09-16 Tempus Pro Rainbow - with Capnometry & without BT Dock
05060472442918 - Tempus Pro2022-09-16 Tempus Pro Rainbow - with Capnometry & with BT Dock
05060472442925 - Tempus Pro2022-09-16 Tempus Pro - Printer, SpO2, NIBP, ECG, ETCO2 & Temp
05060472442932 - Tempus Pro2022-09-16 Tempus Pro - Printer, SpO2, NIBP, ECG, ETCO2, Temp & IBP
05060472442949 - Tempus IC22022-09-16 Tempus IC2 Patient Monitor
05060472441423 - Tempus LS-Manual2020-11-10 Tempus LS Mount
05060472441539 - Tempus LS-Manual2020-11-10 Tempus LS Mount Claw Adapter Kit
05060472441942 - Tempus LS-Manual2020-08-14 Tempus LS-Manual Paediatric Electrodes

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