DreamStation PPX1100S10

GUDID 00606959040854

DreamStation BiPAP AVAPS postponement

Respironics, Inc.

Portable electric ventilator
Primary Device ID00606959040854
NIH Device Record Keyb1ebb0a4-11e9-4940-aeb5-c438af9c2fe4
Commercial Distribution StatusIn Commercial Distribution
Brand NameDreamStation
Version Model Number00
Catalog NumberPPX1100S10
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 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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100606959040854 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNSVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

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 Date2016-11-01

On-Brand Devices [DreamStation]

00606959022942DreamStation Cellular Modem, US with Oximetry
00606959022928DreamStation WiFi Accessory, EU
00606959022911DreamStation WiFi Accessory, EU, with PRI Label
00606959022904DreamStation WiFi Accessory, Canada
00606959022898DreamStation WiFi Accessory, US
00606959022881DreamStation Cellular Modem, Japan
00606959022874DreamStation Cellular Modem with Oximetry, Europe
00606959022867DreamStation Cellular Modem with Oximetry, Europe, with PRI Label, Rental
00606959022850DreamStation Cellular Modem, Canada
00606959022652DreamStation Humidifier, Core Pack, Domestic
00606959022645DreamStation Humidifier, Domestic
00606959022638DreamStation Auto BiPAP with Humidifier, American Home Patient
00606959022621DreamStation Auto BiPAP with Heated Humidifier, American Home Patient
00606959022614DreamStation Auto BiPAP, American Home Patient
00606959022607DreamStation BiPAP Pro with Heated Humidifier, American Home Patient
00606959022591DreamStation BiPAP Pro with Humidifier, American Home Patient
00606959022584DreamStation BiPAP Pro, America Home Patient
00606959022577DreamStation Auto CPAP with Heated Humidifier, American Home Patient
00606959022560DreamStation Auto CPAP with Humidifier, American Home Patient
00606959022553DreamStation Auto CPAP, American Home Patient
00606959022546DreamStation Auto BiPAP with Humidifier, Heated Tube, Domestic
00606959022539DreamStation Auto BiPAP with Humidifier, Domestic
00606959022522DreamStation Auto BiPAP, Domestic
00606959022515DreamStation BiPAP Pro with Humidifier, Heated Tube, Domestic
00606959022508DreamStation BiPAP Pro with Humidifier, Domestic
00606959022492DreamStation BiPAP Pro, Domestic
00606959022485DreamStation Auto CPAP with Humidifier, Heated Tube, Domestic
00606959022478DreamStation Auto CPAP with Humidifier, Domestic
00606959022461DreamStation Auto CPAP, Domestic
00606959022454DreamStation CPAP Pro with Heated Humidifier, American Home Patient
00606959022447DreamStation CPAP Pro System with Humidifier, American Home Patient
00606959022430DreamStation CPAP Pro, American Home Patient
00606959022423DreamStation CPAP Pro with Humidifier, Heated Tube, Domestic
00606959022416DreamStation CPAP Pro with Humidifier, Domestic
00606959022409DreamStation CPAP Pro, Domestic
00606959022393DreamStation CPAP with Heated Humidifier, American Home Patient
00606959022386DreamStation CPAP with Humidifier, American Home Patient
00606959022379DreamStation CPAP with Humidifier, Heated Tube, Domestic
00606959022362DreamStation CPAP with Humidifier, Domestic
00606959022331DreamStation 15mm Heated Tube
00606959022188DreamStation CPAP, American Home Patient
00606959054776DreamStation Auto CPAP System with Humidifier, Heated Tubing, and Cellular Modem, USA
00606959054769DreamStation Auto CPAP System with Humidifier and Cellular Modem, USA
00606959054653DreamStation AVAPS30, BRAZIL, No Bluetooth
00606959054646DreamStation ST30, BRAZIL, No Bluetooth
00606959053304DreamStation Auto CPAP with Auto-Trial, for Brazil
00606959053298DreamStation CPAP Pro with CPAP Check, for Brazil
00606959053281DreamStation CPAP Pro with CPAP Check, Humidifier, and Heated Tubing for China
00606959053274DreamStation Auto CPAP with Auto-Trial, Humidifier, and Heated Tubing for China
00606959053267DreamStation Auto CPAP with Auto-Trial and Humidifier, for China

Trademark Results [DreamStation]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DREAMSTATION
DREAMSTATION
79170804 4995378 Live/Registered
Koninklijke Philips N.V.
2015-06-25
DREAMSTATION
DREAMSTATION
77607776 3855395 Dead/Cancelled
CHOI, HYUN WHAN
2008-11-05
DREAMSTATION
DREAMSTATION
77020980 not registered Dead/Abandoned
Choi, Hyun Whan
2006-10-13
DREAMSTATION
DREAMSTATION
75670425 2611133 Dead/Cancelled
Logic 3 International Limited
1999-03-30

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.