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
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
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
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
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

Devices Manufactured by Covidien LP

10884521739949 - Hugo RAS2026-01-12 Monopolar Curved Shears
10884521826694 - Hugo RAS2026-01-12 Monopolar Curved Shears
10884521844575 - Hugo RAS2026-01-12 Monopolar Curved Shears
10884521850941 - Hugo RAS2026-01-12 Monopolar Curved Shears
10884521850958 - Hugo RAS2026-01-12 Bipolar Fenestrated Grasper
10884521850965 - Hugo RAS2026-01-12 Bipolar Maryland Forceps
10884521850972 - Hugo RAS2026-01-12 Large Needle Driver
10884521740037 - Hugo RAS2026-01-06 Secure Cadiere Forceps

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

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.