SAFIRA 900059

GUDID 05060727270068

SAFIRA System hand operator for controlling SAFIRA Driver

MEDOVATE LIMITED

Pain management medication delivery system
Primary Device ID05060727270068
NIH Device Record Keya19078e3-3247-48ca-9c70-98603037732c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSAFIRA
Version Model NumberSAFIRA Palm Operator
Catalog Number900059
Company DUNS223136416
Company NameMEDOVATE LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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

Customer Support Contacts

Phone+4401223901991
Emailenquires@medovate.co.uk
Phone+4401223901991
Emailenquires@medovate.co.uk
Phone+4401223901991
Emailenquires@medovate.co.uk
Phone+4401223901991
Emailenquires@medovate.co.uk
Phone+4401223901991
Emailenquires@medovate.co.uk
Phone+4401223901991
Emailenquires@medovate.co.uk
Phone+4401223901991
Emailenquires@medovate.co.uk
Phone+4401223901991
Emailenquires@medovate.co.uk
Phone+4401223901991
Emailenquires@medovate.co.uk
Phone+4401223901991
Emailenquires@medovate.co.uk
Phone+4401223901991
Emailenquires@medovate.co.uk
Phone+4401223901991
Emailenquires@medovate.co.uk
Phone+4401223901991
Emailenquires@medovate.co.uk
Phone+4401223901991
Emailenquires@medovate.co.uk
Phone+4401223901991
Emailenquires@medovate.co.uk
Phone+4401223901991
Emailenquires@medovate.co.uk
Phone+4401223901991
Emailenquires@medovate.co.uk
Phone+4401223901991
Emailenquires@medovate.co.uk
Phone+4401223901991
Emailenquires@medovate.co.uk
Phone+4401223901991
Emailenquires@medovate.co.uk
Phone+4401223901991
Emailenquires@medovate.co.uk
Phone+4401223901991
Emailenquires@medovate.co.uk
Phone+4401223901991
Emailenquires@medovate.co.uk
Phone+4401223901991
Emailenquires@medovate.co.uk
Phone+4401223901991
Emailenquires@medovate.co.uk
Phone+4401223901991
Emailenquires@medovate.co.uk
Phone+4401223901991
Emailenquires@medovate.co.uk
Phone+4401223901991
Emailenquires@medovate.co.uk
Phone+4401223901991
Emailenquires@medovate.co.uk

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS105060727270068 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRNPump, Infusion

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-22
Device Publish Date2021-12-10

On-Brand Devices [SAFIRA]

35060727270038Sterile SAFIRA 20 mL syringe (Luer)
05060727270020SAFIRA Driver unit that injects/aspirates works in combination with SAFIRA Foot Pedal and SAFIRA
05060727270013SAFIRA system foot operator for controlling SAFIRA Driver
35060727270052Sterile SAFIRA 20 mL syringe (NRFit)
05060727270068SAFIRA System hand operator for controlling SAFIRA Driver

Trademark Results [SAFIRA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SAFIRA
SAFIRA
88343741 not registered Live/Pending
ICA Independent Capital Advisors SA
2019-03-18
SAFIRA
SAFIRA
86503386 not registered Dead/Abandoned
Philhobar Design Canada Ltd.
2015-01-14
SAFIRA
SAFIRA
85571193 4229782 Dead/Cancelled
Sorrenti Inspirations Limited
2012-03-16
SAFIRA
SAFIRA
79281159 not registered Live/Pending
Medovate Limited
2020-01-24
SAFIRA
SAFIRA
75862503 not registered Dead/Abandoned
Safira Consulting & Communication
1999-12-02

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