Oridion N85

GUDID 10884521172043

Portable Bedside Capnograph/Pulse Oximeter

Covidien LP

Carbon dioxide monitor
Primary Device ID10884521172043
NIH Device Record Key05e217e6-becb-438b-9717-3479465681ec
Commercial Distribution Discontinuation2020-09-11
Commercial Distribution StatusNot in Commercial Distribution
Brand NameOridion
Version Model NumberN85
Catalog NumberN85
Company DUNS058614483
Company NameCovidien LP
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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(508)261-8000
EmailCovidien.UDI@covidien.com
Phone+1(508)261-8000
EmailCovidien.UDI@covidien.com
Phone+1(508)261-8000
EmailCovidien.UDI@covidien.com
Phone+1(508)261-8000
EmailCovidien.UDI@covidien.com
Phone+1(508)261-8000
EmailCovidien.UDI@covidien.com
Phone+1(508)261-8000
EmailCovidien.UDI@covidien.com
Phone+1(508)261-8000
EmailCovidien.UDI@covidien.com
Phone+1(508)261-8000
EmailCovidien.UDI@covidien.com
Phone+1(508)261-8000
EmailCovidien.UDI@covidien.com
Phone+1(508)261-8000
EmailCovidien.UDI@covidien.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, Keep Dry, This side up
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, Keep Dry, This side up
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, Keep Dry, This side up
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, Keep Dry, This side up
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, Keep Dry, This side up
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, Keep Dry, This side up
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, Keep Dry, This side up
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, Keep Dry, This side up
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, Keep Dry, This side up
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS110884521172043 [Primary]

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 Number4
Public Version Date2025-06-13
Device Publish Date2016-09-25

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20884521047652 - Premium Poly CS2025-06-13 C-Section Stapler with Polysorb Staples
20884521067902 - Laparofan2025-06-13 V-Shaped Retractor
10884521084575 - WarmTouch2025-06-13 Patient Warming System, Patient Warming Unit HEPA filter (5200/5800)
10884521129689 - BIS2025-06-13 Monitoring System,Refurbished,For View Monitors
10884521130296 - BIS2025-06-13 BISX Module,Refurbished, Software Version 1.13,For Mindray Monitors

Trademark Results [Oridion]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ORIDION
ORIDION
77021560 3547307 Live/Registered
Oridion Medical 1987 Ltd.
2006-10-16
ORIDION
ORIDION
77021558 3547306 Dead/Cancelled
Oridion Medical 1987 Ltd.
2006-10-16
ORIDION
ORIDION
75494986 2344533 Live/Registered
ORIDION MEDICAL 1987 LTD.
1998-06-01

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