System One DS6HFLG

GUDID 00606959032149

System One Heated Humidifier Assembly, Domestic

Respironics, Inc.

Heated respiratory humidifier
Primary Device ID00606959032149
NIH Device Record Key381c1e0e-4371-409c-b82e-34d8697da165
Commercial Distribution StatusIn Commercial Distribution
Brand NameSystem One
Version Model Number00
Catalog NumberDS6HFLG
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 Datetrue
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
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100606959032149 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Number3
Public Version Date2018-07-06
Device Publish Date2016-08-12

On-Brand Devices [System One]

00606959021914System One Humidifier, Oxygen Health
00606959021877System One Heated Humidifier, ND
00606959021860System One Heated Humidifier, ND
00606959014251System One Heated Humidifier, International
00606959014244System One Heated Humidifier, International
00606959006652System One Q2011 Heated Tube Assembly
00606959004702System One Performance Tubing, 6 ft, 15mm
00606959032149System One Heated Humidifier Assembly, Domestic
00606959032132System One Heated Humidifier Assembly, Domestic
00606959032125System One Heated Humidifier with Tube Assembly, Japan
00606959032118System One Heated Humidifier Assembly, International
00606959032101System One Heated Humidifier Assembly, Japan
00606959032095System One Heated Humidifier Assembly, International
00606959029361System One Heated Humidifier, Spain
00606959029354System One Heated Humidifier, Norway
00606959029347System One Heated Humidifier, Sweden
00606959029330System One Heated Humidifier, Finland
00606959029323System One Heated Humidifier, Great Britain
00606959029309System One Heated Humidifier, Spain
00606959029293System One Heated Humidifier, Norway
00606959029286System One Heated Humidifier, Sweden
00606959029279System One Heated Humidifier, Finland
00606959029262System One Heated Humidifier, Great Britain
00606959029255System One Heated Tube Humidifier, Japan
00606959029248System One Heated Humidifier, Japan
00606959029200System One Heated Humidifier without Tube, Canada
00606959029378System One Heated Humidifier, Portugal
00606959029316System One Heated Humidifier, Portugal
00606959025011System One Heated Humidifier, ZA
00606959050754System One Bluetooth Accessory Module, China
00606959029385System One Heated Humidifier, Oxigen Salud, Spain
00606959057845System One Heated Humidifier, International
00606959057838System One Heated Humidifier, France

Trademark Results [System One]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SYSTEM ONE
SYSTEM ONE
90782681 not registered Live/Pending
Horvath, Thomas M.
2021-06-18
SYSTEM ONE
SYSTEM ONE
85325034 not registered Dead/Abandoned
Move, Inc.
2011-05-19
SYSTEM ONE
SYSTEM ONE
85047908 not registered Dead/Abandoned
Robell Research, Inc.
2010-05-26
SYSTEM ONE
SYSTEM ONE
79056996 not registered Dead/Abandoned
System One - Gesellschaft für technologiegestützte Kommunikationsprozesse m.b.H
2008-05-09
SYSTEM ONE
SYSTEM ONE
78782151 not registered Dead/Abandoned
Amadeus Global Travel Distribution, S.A.
2005-12-29
SYSTEM ONE
SYSTEM ONE
78519165 3238053 Dead/Cancelled
System One Innovations, Inc.
2004-11-18
SYSTEM ONE
SYSTEM ONE
78214470 not registered Dead/Abandoned
Bicycle Sports, Inc.
2003-02-13
SYSTEM ONE
SYSTEM ONE
78157734 2953045 Dead/Cancelled
PORRAZZO, WILLIAM
2002-08-26
SYSTEM ONE
SYSTEM ONE
78157734 2953045 Dead/Cancelled
Horvath, Sandra R.
2002-08-26
SYSTEM ONE
SYSTEM ONE
77875180 3898749 Live/Registered
Rescuecom Corporation
2009-11-18
SYSTEM ONE
SYSTEM ONE
77512080 not registered Dead/Abandoned
Andersen Corporation
2008-07-01
SYSTEM ONE
SYSTEM ONE
77374423 3528919 Live/Registered
System One Holdings, LLC
2008-01-17

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