ResScan 31336

GUDID 00619498313365

ResScan V6.1 CD ASSY

RESMED LIMITED

Ventilator application software Ventilator application software Ventilator application software Ventilator application software Ventilator application software Ventilator application software Ventilator application software Ventilator application software Ventilator application software Ventilator application software Ventilator application software Ventilator application software Ventilator application software
Primary Device ID00619498313365
NIH Device Record Keyffaff842-3eb8-4632-9e58-12eaab143f20
Commercial Distribution StatusIn Commercial Distribution
Brand NameResScan
Version Model Number31336
Catalog Number31336
Company DUNS751149311
Company NameRESMED 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

Customer Support Contacts

Phone1.800.424.0737
Emailreception@resmed.com
Phone1.800.424.0737
Emailreception@resmed.com
Phone1.800.424.0737
Emailreception@resmed.com
Phone1.800.424.0737
Emailreception@resmed.com
Phone1.800.424.0737
Emailreception@resmed.com
Phone1.800.424.0737
Emailreception@resmed.com
Phone1.800.424.0737
Emailreception@resmed.com
Phone1.800.424.0737
Emailreception@resmed.com
Phone1.800.424.0737
Emailreception@resmed.com
Phone1.800.424.0737
Emailreception@resmed.com
Phone1.800.424.0737
Emailreception@resmed.com
Phone1.800.424.0737
Emailreception@resmed.com
Phone1.800.424.0737
Emailreception@resmed.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100619498313365 [Primary]
GS100619498313365 [Primary]
GS100619498313365 [Primary]
GS100619498313365 [Primary]
GS100619498313365 [Primary]
GS100619498313365 [Primary]
GS100619498313365 [Primary]
GS100619498313365 [Primary]
GS100619498313365 [Primary]
GS100619498313365 [Primary]
GS100619498313365 [Primary]
GS100619498313365 [Primary]
GS100619498313365 [Primary]

FDA Product Code

MNSVentilator, Continuous, Non-Life-Supporting
MNSVentilator, Continuous, Non-Life-Supporting
MNSVentilator, Continuous, Non-Life-Supporting
MNSVentilator, Continuous, Non-Life-Supporting
MNSVentilator, Continuous, Non-Life-Supporting
MNSVentilator, Continuous, Non-Life-Supporting
MNSVentilator, Continuous, Non-Life-Supporting
MNSVentilator, Continuous, Non-Life-Supporting
MNSVentilator, Continuous, Non-Life-Supporting
MNSVentilator, Continuous, Non-Life-Supporting
MNSVentilator, Continuous, Non-Life-Supporting
MNSVentilator, Continuous, Non-Life-Supporting
MNSVentilator, Continuous, Non-Life-Supporting

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-15
Device Publish Date2020-09-07

On-Brand Devices [ResScan]

00619498313334RESSCAN V6.0 CD ASSY
00619498313327RESSCAN V 5.9 CD ASSY
00619498313303RESSCAN V 5.8 CD ASSY
00619498313297RESSCAN V 5.7 CD ASSY
00619498313273RESSCAN V 5.5 CD ASSY
00619498313020Patient data management software (web version)
00619498229154RESSCAN DATA CARD MODULE
00619498222070RESSCAN DATA CARD READER
00619498222032RESSCAN USB ADAPTER
00619498000722Patient data management software (web version)
00619498313341RESSCAN V6.0.1 CD ASSY
00619498313358RESSCAN V6.0.2 CD ASSY
00619498313365ResScan V6.1 CD ASSY

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