CT2 EFFORT SENSOR P1587

GUDID 00606959010895

CT2 Effort Respiratory Sensor, Pediatric, Alice 5

Respironics, Inc.

Polysomnograph
Primary Device ID00606959010895
NIH Device Record Key97f0666e-e285-420a-96e3-bb95958a8e56
Commercial Distribution StatusIn Commercial Distribution
Brand NameCT2 EFFORT SENSOR
Version Model Number00
Catalog NumberP1587
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 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
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 -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
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
GS100606959010895 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BZQMonitor, breathing frequency

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 Date2016-09-02

On-Brand Devices [CT2 EFFORT SENSOR]

00606959010925CT2 Effort Sensor, Adult, Alice 3
00606959010901CT2 Effort Sensor, Adult, Alice 4
00606959010895CT2 Effort Respiratory Sensor, Pediatric, Alice 5
00606959010871CT2 Effort Sensor, Adult, Stardust

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