Tempus LS-Manual

GUDID 05060472441539

Tempus LS Mount Claw Adapter Kit

REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED

Portable system mount Portable system mount Portable system mount Portable system mount
Primary Device ID05060472441539
NIH Device Record Key3d737fa3-eb99-4e6c-9398-2aaa87bcea55
Commercial Distribution StatusIn Commercial Distribution
Brand NameTempus LS-Manual
Version Model Number01-3025
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 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
GS105060472441539 [Primary]
GS105060472441539 [Primary]
GS105060472441539 [Primary]
GS105060472441539 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LDDDc-Defibrillator, Low-Energy, (Including Paddles)
LDDDc-Defibrillator, Low-Energy, (Including Paddles)
LDDDc-Defibrillator, Low-Energy, (Including Paddles)
LDDDc-Defibrillator, Low-Energy, (Including Paddles)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-10
Device Publish Date2020-11-02

On-Brand Devices [Tempus LS-Manual]

05060472441973Tempus LS-Manual CPR Feedback Sensor
05060472441966Tempus LS-Manual Securing Pads
05060472441959Tempus LS-Manual Adult Electrodes
05060472441942Tempus LS-Manual Paediatric Electrodes
05060472441539Tempus LS Mount Claw Adapter Kit
05060472441423Tempus LS Mount

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