DreamWear Full 1133388

GUDID 00606959046108

MW, DreamWear Full, Sm Frm W HGR, GBL

Respironics, Inc.

CPAP/BPAP nasal mask, reusable
Primary Device ID00606959046108
NIH Device Record Key74b6afbd-0092-402f-94c3-319e2cf62f00
Commercial Distribution StatusIn Commercial Distribution
Brand NameDreamWear Full
Version Model Number00
Catalog Number1133388
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 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
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
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
GS100606959046108 [Primary]

FDA Product Code

BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR)

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 Date2017-12-13

On-Brand Devices [DreamWear Full]

00606959046344DreamWear Full Face Mask, Medium-Wide Cushion, Small and Medium Frame, International version
00606959046337DreamWear Full Face Mask, Large Cushion, Small and Medium Frame, International Version
00606959046320DreamWear Full Face Mask, Medium Cushion, Small and Medium Frame, International version
00606959046313DreamWear Full Face Mask, Small Cushion, Small and Medium Frame, International Version
00606959046306MW, DreamWear Full, Sm Med Frm, GBL
00606959046290L, DreamWear Full, Sm Med Frm, GBL
00606959046283M, DreamWear Full, Sm Med Frm, GBL
00606959046276S, DreamWear Full, Sm Med Frm, GBL
00606959046146MW, DreamWear Full, Lg Frm W HGR, GBL
00606959046139L, DreamWear Full, Lg Frm W HGR, GBL
00606959046122M, DreamWear Full, Lg Frm W HGR, GBL
00606959046115S, DreamWear Full, Lg Frm W HGR, GBL
00606959046108MW, DreamWear Full, Sm Frm W HGR, GBL
00606959046092L, DreamWear Full, Sm Frm W HGR, GBL
00606959046085M, DreamWear Full, Sm Frm W HGR, GBL
00606959046078S, DreamWear Full, Sm Frm W HGR, GBL
00606959046061MW, DreamWear Full, Med Frm W HGR, GBL
00606959046054L, DreamWear Full, Med Frm W HGR, GBL
00606959046047M, DreamWear Full, Med Frm W HGR, GBL
00606959046030S, DreamWear Full, Med Frm W HGR, GBL
00606959046023MW, DreamWear Full, Lg Frm WO HGR, GBL
00606959046016L, DreamWear Full, Lg Frm WO HGR, GBL
00606959046009M, DreamWear Full, Lg Frm WO HGR, GBL
00606959045996S, DreamWear Full, Lg Frm WO HGR, GBL
00606959045989MW, DreamWear Full, Sm Frm WO HGR, GBL
00606959045972L, DreamWear Full, Sm Frm WO HGR, GBL
00606959045958S, DreamWear Full, Sm Frm WO HGR, GBL
00606959045941MW, DreamWear Full, Med Frm WO HGR, GBL
00606959045934L, DreamWear Full, Med Frm WO HGR, GBL
00606959045927M, DreamWear Full, Med Frm WO HGR, GBL
00606959045910S, DreamWear Full, Med Frm WO HGR, GBL
00606959045897DreamWear Full, Med Frame W HGR, GBL
00606959045880DreamWear Full, FitPack
00606959054448Small, DreamWear Full, Medium Frame WithHeadgear, United States of America
00606959058385Medium DreamWear Full Small Medium Frame, Ukraine
00606959058378Small DreamWear Full Small Medium Frame Ukraine
00606959046368Wide, DreamWear Full Face Mask, Medium Frame with Headgear, Japan
00606959046221Small Medium, DreamWear Full Face Mask, Large Frame with Headgear, Japan
00606959046214Small Medium, DreamWear Full Face Mask, Medium Frame with Headgear, Japan
00606959046207Small Medium, DreamWear Full Face Mask, Small Frame with Headgear, Japan
00606959061088Medium Wide, DreamWear Full, Small and Medium Frame, Ukraine
00606959061071Large, DreamWear Full, Small and Medium Frame, Ukraine
00606959062535Medium Wide, DreamWear Full, Small and Medium Frame, China
00606959062528Small Wide, DreamWear Full, Small and Medium Frame, China

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