AIRFIT F20 63457

GUDID 00619498634576

AIRFIT F20 CUSHION SML

RESMED LIMITED

CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable
Primary Device ID00619498634576
NIH Device Record Key8a17f8c5-af9a-4662-8094-c3beb0ef2195
Commercial Distribution StatusIn Commercial Distribution
Brand NameAIRFIT F20
Version Model Number63457
Catalog Number63457
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

Operating and Storage Conditions

Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100619498634576 [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 Date2020-07-02
Device Publish Date2020-06-24

On-Brand Devices [AIRFIT F20]

00619498634767AirFit F20 Elbow
00619498634750AirFit F20 Headgear Clip
00619498634736AIRFIT F20 FOR HER HEADGEAR STD
00619498634729AIRFIT F20 HEADGEAR LGE
00619498634712AIRFIT F20 HEADGEAR STD
00619498634705AIRFIT F20 HEADGEAR SML
00619498634699AIRFIT F20 CUSHION LGE
00619498634682AIRFIT F20 CUSHION MED
00619498634675AIRFIT F20 CUSHION SML
00619498634668AIRFIT F20 FOR HER FRAME
00619498634651AIRFIT F20 FRAME
00619498634644AIRFIT F20 FOR HER FRAME SYS MED
00619498634637AIRFIT F20 FOR HER FRAME SYS SML
00619498634620AIRFIT F20 FRAME SYS LGE
00619498634613AIRFIT F20 FRAME SYS MED
00619498634606AIRFIT F20 FRAME SYS SML
00619498634569AIRFIT F20 FOR HER STARTER PACK
00619498634507AIRFIT F20 STARTER PACK
00619498634491AIRFIT F20 FOR HER MED - SLM
00619498634484AIRFIT F20 FOR HER SML - SLM
00619498634477AIRFIT F20 LGE SYS - SLM
00619498634460AIRFIT F20 MED SYS - SLM
00619498634453AIRFIT F20 SML SYS - SLM
00619498634040AIRFIT F20 FOR HER MED
00619498634033AIRFIT F20 FOR HER SML
00619498634026AIRFIT F20 LGE
00619498634019AIRFIT F20 MED
00619498634002AIRFIT F20 SML
00619498002986AIRFIT F20 LGE HEADGEAR - SLM
00619498002429AIRFIT F20 STD HEADGEAR - SLM
00619498002979AIRFIT F20 SML HEADGEAR - SLM
00619498634941F20 QUIETAIR ELBOW
00619498634590AIRFIT F20 CUSHION LGE
00619498634583AIRFIT F20 CUSHION MED
00619498634576AIRFIT F20 CUSHION SML
00619498634422AIRFIT F20 FRAME SYS LGE
00619498634415AIRFIT F20 FRAME SYS MED
00619498634408AIRFIT F20 FRAME SYS SML
00619498634972AIRFIT F20 HEADGEAR LGE
00619498634965AIRFIT F20 HEADGEAR STD
00619498634958AIRFIT F20 HEADGEAR SML
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