AIR 11 39018

GUDID 00619498390182

AIRCURVE 11 VAUTO USA CO

RESMED PTY LTD

Home BPAP unit
Primary Device ID00619498390182
NIH Device Record Key4f7e9107-2996-4a0d-906f-c861f600ea77
Commercial Distribution StatusIn Commercial Distribution
Brand NameAIR 11
Version Model Number39018
Catalog Number39018
Company DUNS751149311
Company NameRESMED PTY LTD
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 Latexfalse
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

Operating and Storage Conditions

Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100619498390182 [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 Date2023-11-08
Device Publish Date2023-10-31

On-Brand Devices [AIR 11]

00619498390199AIRCURVE 11 VAUTO USA TRI
00619498390182AIRCURVE 11 VAUTO USA CO
00619498390137AIRCURVE 11 ASV USA TRI
00619498390120AIRCURVE 11 ASV USA CO

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