Tempus IC

GUDID 05060472440600

Lo-Flo® Sidestream Capnometer

REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED

Transportable physiologic monitoring system Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical Multiple vital physiological parameter monitoring system, clinical
Primary Device ID05060472440600
NIH Device Record Keye4709b9d-756b-4a74-a194-72bebb835dd6
Commercial Distribution StatusIn Commercial Distribution
Brand NameTempus IC
Version Model Number01-1005
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 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
GS105060472440600 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MWIMonitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-16

On-Brand Devices [Tempus IC]

05060472440709Consumables Replenishment Kit
05060472440693Mains Power Supply
0506047244068612-Lead ECG Harness
0506047244067900-1001
05060472440600Lo-Flo® Sidestream Capnometer

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