Tempus IC2

GUDID 05060472440495

REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED

Transportable physiologic monitoring system
Primary Device ID05060472440495
NIH Device Record Keyee3af831-80df-4466-bbf3-ec618a924d69
Commercial Distribution StatusIn Commercial Distribution
Brand NameTempus IC2
Version Model Number00-2001-S
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 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
GS105060472440495 [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 IC2]

05060472440594Tempus Lithium-ion Battery (Orange)
0506047244050100-2001-T
0506047244049500-2001-S
0506047244048800-2001-R
05060472440464Tempus 12-Lead Electrocardiogram Harness
05060472440457Glucometer Replenishment Kit
05060472440440Consumables Replenishment Kit
0506047244043301-2506
05060472442949Tempus IC2 Patient Monitor

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