CLIMATELINEAIR 11 39102

GUDID 00619498003273

CLIMATELINEAIR 11 AMER

RESMED LIMITED

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Primary Device ID00619498003273
NIH Device Record Keyb42762b8-0cb0-4b11-a767-5884910076aa
Commercial Distribution StatusIn Commercial Distribution
Brand NameCLIMATELINEAIR 11
Version Model Number39102
Catalog Number39102
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100619498003273 [Direct Marking]
GS100619498391028 [Primary]

FDA Product Code

BZDVentilator, Non-Continuous (Respirator)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-08
Device Publish Date2021-03-31

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00619498391004 - HUMIDAIR11 STANDARD2021-04-08 HUMIDAIR11 STANDARD TUB
00619498003273 - CLIMATELINEAIR 112021-04-08CLIMATELINEAIR 11 AMER
00619498003273 - CLIMATELINEAIR 112021-04-08 CLIMATELINEAIR 11 AMER
00619498392056 - AIR 112021-04-08 AIR 11 PSU 65W USA
00619498392209 - AIR 112021-04-08 AIR 11 AIR OUTLET
00619498393008 - AIR 112021-04-08 AIR 11 FILTER STD 1 PK
00619498393015 - AIR 112021-04-08 AIR 11 FILTER, STD 2 PK
00619498272068 - ResMed Connectivity Module2021-02-19 Connectivity Module (RCM)

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