AF541 1133713

GUDID 30606959046642

AF541 SE UTN, FOUR POINT HEADGEAR, SIZE A

Respironics, Inc.

CPAP/BPAP face mask, single-use
Primary Device ID30606959046642
NIH Device Record Key3760842d-0e66-430e-89c6-71f71a1ca6de
Commercial Distribution StatusIn Commercial Distribution
Brand NameAF541
Version Model Number00
Catalog Number1133713
Company DUNS080728314
Company NameRespironics, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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

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
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
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
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
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
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 HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100606959046641 [Primary]
GS130606959046642 [Package]
Contains: 00606959046641
Package: Multipack [10 Units]
In Commercial Distribution

FDA Product Code

CBKVENTILATOR, CONTINUOUS, FACILITY USE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-07-20

On-Brand Devices [AF541]

30606959046703AF541 SE UTN,Capstrap, SIZE C
30606959046697AF541 SE UTN, Capstrap, SIZE B
30606959046680AF541 SE UTN, Capstrap, SIZE A
30606959046673AF541 SE UTN, Capstrap, EXTRA SMALL
30606959046666AF541 SE UTN, FOUR POINT HEADGEAR, SIZE C
30606959046659AF541 SE UTN, FOUR POINT HEADGEAR, SIZE B
30606959046642AF541 SE UTN, FOUR POINT HEADGEAR, SIZE A
30606959046635AF541 SE UTN, FOUR POINT HEADGEAR, EXTRA SMALL
30606959046628AF541 EE Leak 2 UTN,Capstrap, SIZE C
30606959046611AF541 EE Leak 2 UTN, Capstrap, SIZE B
30606959046604AF541 EE Leak 2 UTN, Capstrap, SIZE A
30606959046598AF541 Non-Invasive Mask with EE Leak 2 elbow, Under the Chin cushion with Capstrap, XS
30606959046581AF541 EE Leak 2 UTN, FOUR POINT HEADGEAR, SIZE C
30606959046574AF541 EE Leak 2 UTN, FOUR POINT HEADGEAR, SIZE B
30606959046567AF541 EE Leak 2 UTN, FOUR POINT HEADGEAR, SIZE A
30606959046550AF541 EE Leak 2 UTN, FOUR POINT HEADGEAR, EXTRA SMALL
30606959046543AF541 EE LEAK 1 UTN, CAPSTRAP, INTL, SIZE C
30606959046536AF541 EE LEAK 1 UTN, CAPSTRAP, INTL, SIZE B
30606959046529AF541 EE LEAK 1 UTN, CAPSTRAP, INTL, SIZE A
30606959046512AF541 EE LEAK 1 UTN, CAPSTRAP, INTL, EXTRA SMALL
30606959046505AF541 EE LEAK 1 UTN, FOUR POINT HEADGEAR, INTL, SIZE C
30606959046499AF541 EE LEAK 1 UTN, FOUR POINT HEADGEAR, INTL, SIZE B
30606959046482AF541 EE LEAK 1 UTN, FOUR POINT HEADGEAR, INTL, SIZE A
30606959046475AF541 EE LEAK 1 UTN, FOUR POINT HEADGEAR, INTL, EXTRA SMALL
30606959046468AF541 EE LEAK 1 UTN, CAPSTRAP, US, SIZE C
30606959046451AF541 EE LEAK 1 UTN, CAPSTRAP, US, SIZE B
30606959046444AF541 EE LEAK 1 UTN, CAPSTRAP, US, SIZE A
30606959046437AF541 EE LEAK 1 UTN, CAPSTRAP, US, EXTRA SMALL
30606959046420AF541 EE LEAK 1 UTN, FOUR POINT HEADGEAR, US, SIZE C
30606959046413AF541 EE LEAK 1 UTN, FOUR POINT HEADGEAR, US, SIZE B
30606959046406AF541 EE LEAK 1 UTN, FOUR POINT HEADGEAR, US, SIZE A
30606959046390AF541 EE LEAK 1 UTN, 4PT HEADGEAR, US, EXTRA SMALL
30606959041388AF541 SE with Capstrap, Size XL, JPN
30606959041371AF541 SE with Capstrap, Size L, JPN
30606959041364AF541 SE with Capstrap, Size M, JPN
30606959041357AF541 SE with Capstrap, Size S, JPN
30606959041340AF541 SE Nasal Mask - Under the Nose Cushion with Capstrap - Replacement Part Size XS, Japan
30606959041333AF541 SE UTN with Capstrap, Size C, JPN
30606959041326AF541 SE UTN with Capstrap, Size B, JPN
30606959041319AF541 SE UTN with Capstrap, Size A, JPN
30606959041302AF541 EE Leak 1 with Capstrap, Size XL, JPN
30606959041296AF541 EE Leak 1 with Capstrap, Size L, JPN
30606959041289AF541 EE Leak 1 with Capstrap, Size M, JPN
30606959041272AF541 EE Leak 1 with Capstrap, Size S, JPN
30606959041265AF541 EE Leak 2 UTN with Capstrap, Size B, JPN
30606959041258AF541 EE Leak 1 UTN with Capstrap, Size XS, JPN
30606959041241AF541 EE Leak 1 UTN with Capstrap, Size C, JPN
30606959041234AF541 EE Leak 1 UTN with Capstrap, Size B, JPN
30606959041227AF541 EE Leak 1 UTN with Capstrap, Size A, JPN
30606959038845AF541 Sizing Gauge

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