Exchange CO2 Sensor, NICO C3 U9567-37

GUDID 00884838033870

RESPIRONICS NOVAMETRIX, LLC

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Primary Device ID00884838033870
NIH Device Record Keyaa086e4e-e04d-4323-80df-2a28fe79856e
Commercial Distribution StatusIn Commercial Distribution
Brand NameExchange CO2 Sensor, NICO C3
Version Model Number00
Catalog NumberU9567-37
Company DUNS093608594
Company NameRESPIRONICS NOVAMETRIX, LLC
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

Operating and Storage Conditions

Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100884838033870 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

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 Date2016-09-23

Devices Manufactured by RESPIRONICS NOVAMETRIX, LLC

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00884838104785 - Respironics2024-02-23 Pediatric/Adult Airway Adapter
00884838104792 - Respironics2024-02-23 Neonatal/Pediatric Airway Adapter
00884838104884 - Respironics2024-02-23 Cannula Nasal CO2/O2 Adult
00884838104891 - Respironics2024-02-23 Cannula Nasal CO2/O2 Infant

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