AIR 10 37394

GUDID 00619498373949

AIR 10 TUBING ELBOW

RESMED LIMITED

Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Ventilator breathing circuit, reusable Ventilator breathing circuit, reusable Ventilator breathing circuit, reusable Ventilator breathing circuit, reusable Ventilator breathing circuit, reusable Ventilator breathing circuit, reusable Ventilator breathing circuit, reusable Ventilator breathing circuit, reusable Ventilator breathing circuit, reusable Ventilator breathing circuit, reusable Ventilator breathing circuit, reusable Ventilator breathing circuit, reusable Ventilator breathing circuit, reusable Ventilator breathing circuit, reusable Ventilator breathing circuit, reusable Ventilator breathing circuit, reusable Ventilator breathing circuit, reusable
Primary Device ID00619498373949
NIH Device Record Keyafd2d409-cf12-45e8-88d2-1889bc3d5e63
Commercial Distribution StatusIn Commercial Distribution
Brand NameAIR 10
Version Model Number37394
Catalog Number37394
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com

Operating and Storage Conditions

Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100619498373949 [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 Date2020-07-09
Device Publish Date2020-07-01

On-Brand Devices [AIR 10]

00619498373444AIR 10 PSU 90W
00619498373352AIR 10 SIDE COVER GRAY
00619498373109AIR 10 AIR OUTLET
00619498373093AIR 10 90W PSU
00619498373031AIR 10 SIDE COVER CHARCOAL
00619498373024AIR 10 OXIMETRY MODULE
00619498373017AIR 10 USB MODULE
00619498372973DC-DC CONVERTER
00619498373949AIR 10 TUBING ELBOW

Trademark Results [AIR 10]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AIR 10
AIR 10
78860645 3282867 Dead/Cancelled
MJC ACQUISITION, LLC
2006-04-13

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.