System One, 60 Series DS6TFLGC

GUDID 00606959043039

System One Heated Humidifier, Assembly - Coverted, Domestic

Respironics, Inc.

Heated respiratory humidifier
Primary Device ID00606959043039
NIH Device Record Key16589db9-d133-4d5f-8a6d-ff3a96775fa8
Commercial Distribution StatusIn Commercial Distribution
Brand NameSystem One, 60 Series
Version Model Number00
Catalog NumberDS6TFLGC
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

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 -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

Device Identifiers

Device Issuing AgencyDevice ID
GS100606959043039 [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 Date2016-09-14

On-Brand Devices [System One, 60 Series]

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00606959037953REMstar Plus Assembly, Brazil
00606959037946BiPAP Pro Series Assembly, Brazil
00606959037939BiPAP Auto Series Assembly, Brazil
00606959037922System One 60 Series, REMstar Pro C-Flex, France
00606959037915System One 60 Series, REMstar Auto A-Flex, France
00606959037892System One, 60 Series, REMstar Auto A-Flex, Germany
00606959037878Somnia 3i CPAP System with C-Flex Plus (System One H&L)
00606959037779System One, 60 Series, REMstar Auto with Heated Humidifer, Standard Tube, with Bluetooth, Canada
00606959037762System One, 60 Series, REMstar Auto with Heated Humidifier, BlueTooth, Canada

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