Dreamwear 1125016KR

GUDID 00606959059658

Medium DreamWear Gel Pillows Medium Frame with Headgear Korea

Respironics, Inc.

CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable
Primary Device ID00606959059658
NIH Device Record Key3e600d4e-2850-44ce-bb90-5180b8829795
Commercial Distribution StatusIn Commercial Distribution
Brand NameDreamwear
Version Model Number00
Catalog Number1125016KR
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)387-4000
EmailRESPIRONICS.SERVICE@PHILIPS.COM
Phone+1(724)387-4000
EmailRESPIRONICS.SERVICE@PHILIPS.COM
Phone+1(724)387-4000
EmailRESPIRONICS.SERVICE@PHILIPS.COM
Phone+1(724)387-4000
EmailRESPIRONICS.SERVICE@PHILIPS.COM
Phone+1(724)387-4000
EmailRESPIRONICS.SERVICE@PHILIPS.COM
Phone+1(724)387-4000
EmailRESPIRONICS.SERVICE@PHILIPS.COM
Phone+1(724)387-4000
EmailRESPIRONICS.SERVICE@PHILIPS.COM
Phone+1(724)387-4000
EmailRESPIRONICS.SERVICE@PHILIPS.COM
Phone+1(724)387-4000
EmailRESPIRONICS.SERVICE@PHILIPS.COM
Phone+1(724)387-4000
EmailRESPIRONICS.SERVICE@PHILIPS.COM
Phone+1(724)387-4000
EmailRESPIRONICS.SERVICE@PHILIPS.COM
Phone+1(724)387-4000
EmailRESPIRONICS.SERVICE@PHILIPS.COM
Phone+1(724)387-4000
EmailRESPIRONICS.SERVICE@PHILIPS.COM
Phone+1(724)387-4000
EmailRESPIRONICS.SERVICE@PHILIPS.COM
Phone+1(724)387-4000
EmailRESPIRONICS.SERVICE@PHILIPS.COM

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100606959059658 [Primary]
GS100606959059658 [Primary]
GS100606959059658 [Primary]
GS100606959059658 [Primary]
GS100606959059658 [Primary]
GS100606959059658 [Primary]
GS100606959059658 [Primary]
GS100606959059658 [Primary]
GS100606959059658 [Primary]
GS100606959059658 [Primary]
GS100606959059658 [Primary]
GS100606959059658 [Primary]
GS100606959059658 [Primary]
GS100606959059658 [Primary]
GS100606959059658 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR)
BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR)
BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR)
BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR)
BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR)
BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR)
BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR)
BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR)
BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR)
BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR)
BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR)
BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR)
BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR)
BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR)
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 Date2020-06-23
Device Publish Date2020-06-15

On-Brand Devices [Dreamwear]

0060695902311600
0060695902298000
0060695902232400
00606959052291DreamWear SC UTN Fitpack Japan
00606959052062DreamWear UTN Nasal, Fitpack WHGR, USA
00606959049765DreamWear Gel Pillows, Starter Pack, INTL
00606959049642DreamWear Under the Nose Nasal, Medium Frame w Hgr, Korea
00606959049383Medium Wide, DreamWear Full, Small and Medium Frame, Korea
00606959049376Small Wide, DreamWear Full, Small and Medium Frame, Korea
0060695904936900
00606959049352Small, DreamWear Full, Small and Medium Frame, Korea
00606959048898DreamWear Under the Nose Nasal, Large Frame WHGR, CHN
00606959048881DreamWear Under the Nose Nasal, Medium Frame WHGR, CHN
00606959048874DreamWear Under the Nose Nasal, Small Frame WHGR, CHN
00606959040496S-M DreamWear Under the Nose Nasal, Lg Frame wHeadgear, JPN
00606959040489S-M DreamWear Under the Nose Nasal, Med Frame wHeadgear, JPN
00606959040472S-M DreamWear Under the Nose Nasal, Sm Frame wHeadgear, JPN
00606959040342DreamWear Under the Nose Nasal Mask, Wide Cushion, Medium Frame wHeadgear, Japan
00606959040335M DreamWear Under the Nose Nasal, Med Frame wHeadgear, JPN
00606959040328DreamWear Under the Nose Nasal, Med Frame wHeadgear, JPN
00606959040311W DreamWear Under the Nose Nasal, Lg Frame wHeadgear, JPN
00606959040304M DreamWear Under the Nose Nasal, Lg Frame wHeadgear, JPN
00606959040298W DreamWear Under the Nose Nasal, Sm Frame wHeadgear, JPN
00606959040274M DreamWear Under the Nose, Sm Frame wHeadgear, JPN
00606959037670S-M DreamWear Under the Nose Nasal, Lg Frame wHeadgear, JPN
00606959037656S-M DreamWear Under the Nose Nasal, Sm Frame wHeadgear, JPN
00606959037571DreamWear Under the Nose Nasal, Med Frame wHeadgear, INTL
00606959037564DreamWear Under the Nose Nasal, Fitpack, INTL
00606959031135MW DreamWear Under the Nose Nasal, Lg Frame WO Headgear, GBL
00606959031128L DreamWear Under the Nose Nasal, Large Frame WO Headgear, GBL
00606959031111M DreamWear Under the Nose Nasal, Lg Frame WO Headgear, GBL
00606959031104S DreamWear Under the Nose Nasal, Lg Frame WO Headgear, GBL
00606959031098MW DreamWear Under the Nose Nasal, Sm Frame WO HGR, GBL
00606959031081L DreamWear Under the Nose Nasal, Sm Frame WO Headgear, GBL
00606959031074M DreamWear Under the Nose Nasal, Sm Frame WO Headgear, GBL
00606959031067S DreamWear Under the Nose Nasal, Sm Frame WO HGR, GBL
00606959031050MW DreamWear Under the Nose Nasal, Med Frame WO Headgear, GBL
00606959031043L DreamWear Under the Nose Nasal, Med Frame WO HGR, GBL
00606959031036M DreamWear Under the Nose Nasal, Med Frame WO Headgear, GBL
00606959030961S DreamWear Under the Nose, Med Frame WO Headgear, GBL
00606959030947DreamWear Under the Nose Nasal, Med Frame WO Headgear, GBL
00606959030916DreamWear Under the Nose Nasal, Med Frame wHeadgear, GBL
00606959030909DreamWear Under the Nose Nasal, FitPack
00606959030893MW DreamWear Under the Nose, Lg Frame wHeadgear, GBL
00606959030886L DreamWear Under the Nose, Lg Frame wHeadgear, GBL
00606959030879M DreamWear Under the Nose, Lg Frame wHeadgear, GBL
00606959030862S DreamWear Under the Nose, Large Frame wHeadgear, GBL
00606959030855MW DreamWear Under the Nose, Sm Frame wHeadgear, GBL
00606959030848L DreamWear Under the Nose, Sm Frame wHeadgear, GBL
00606959030824M DreamWear Under the Nose, Sm Frame wHeadgear, GBL

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