BiPAP A40 1109596

GUDID 00606959042742

BiPAP A40, FGD SA, International

Respironics, Inc.

Portable electric ventilator
Primary Device ID00606959042742
NIH Device Record Keya7568641-9dc0-458c-9494-db9461c56e55
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiPAP A40
Version Model Number00
Catalog Number1109596
Company DUNS080728314
Company NameRespironics, Inc.
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 Batchfalse
Serial Numbertrue
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

Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100606959042742 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNTVENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-31

On-Brand Devices [BiPAP A40]

00606959021990BiPAP A40 China
00606959021549BiPAP A40 Australia
00606959048775BiPAP A40, Sapio, Italy
00606959047945BiPAP A40, International, Argentina
00606959043121Philips RI ANIV BiPAP A40 In-Use Carry Case
00606959042834BiPAP A40 Ventilatory Support System Silver Series
00606959042797BiPAP A40 Silver Series FGD SA, Japan
00606959042780BiPAP A40 Ventilatory Support System, France
00606959042773BiPAP A40, FGD SA, China
00606959042766BiPAP A40, FGD SA, Brazil
00606959042759BiPAP A40, FGD SA, International, Private Label
00606959042742BiPAP A40, FGD SA, International
00606959042735BiPAP A40, FGD SA, Domestic
00606959039551BiPAP A40 International, Private Label
00606959039544BiPAP A40 Ventilatory Support System Silver Series, Japan
00606959039537BiPAP A40 Silver Series
00606959039520BiPAP A40 France
00606959039513BiPAP A40 Canada, Heated Tube Core Package
00606959039506BiPAP A40 Canada
00606959039490BiPAP A40 Brazil
00606959039483BiPAP A40 Australia, Core Package
00606959039476BiPAP A40, International
00606959039469BiPAP A40 Domestic
00606959059153BiPAP A40 Pro, Postponement
00606959059146BiPAP A40 EFL, Postponement
00606959056817A40 ProEFL, Detachable Battery Module
00606959055209BiPAP A40 EFL, Intl
00606959055025BiPAP A40 Pro, International
00606959059320BiPAP A40 EFL, Italy
00606959059290BiPAP A40 EFL, France
00606959059122BiPAP A40 Pro, Benelux
00606959058927BiPAP A40 EFL, Spain
00606959055247BiPAP A40 EFL, United Kingdom
00606959055148BiPAP A40 Pro, Italy
00606959055100BiPAP A40 Pro, France
00606959055063BiPAP A40 Pro, United Kingdom
00606959059436BiPAP A40 EFL, Canada with Heated Tube Humidifier
00606959059412BiPAP A40 Pro, Canada with Heated Tube Humidifier
00606959059405BiPAP A40 Pro, CA
00606959059177BiPAP A40 Pro, Australia
00606959059160BiPAP A40 EFL, Australia
00606959058774System One Heated Tube Humidifier, A40 ProEFL, Intl Core Pack
00606959058750System One Heated Humidifier, A40 ProEFL, Intl Core Pack
00606959056862A40 ProEFL, Heated Tube Humidifier, Inernational
00606959056831A40 ProEFL, Heated Humidifier, International
00606959058545A40 ProEFL, System One Heated Tube Humidifier, Italy
00606959058538A40 ProEFL, System One Heated Tube Humidifier, Benelux
00606959058521A40 ProEFL, System One Heated Tube Humidifier, Nordic
00606959058514A40 ProEFL, System One Heated Tube Humidifier, France
00606959058507A40 ProEFL, System One Heated Tube Humidifier, Iberia
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