NanoPod for GE

GUDID 10884521819023

CARESCAPE (TM) CO2-Microstream (TM) Parameter;For use with GE Patient Monitors

Covidien LP

Carbon dioxide monitor

• Primary Device ID: 10884521819023
• NIH Device Record Key: 151861c9-c5f7-42dd-abbb-765970c6370b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NanoPod for GE
• Version Model Number: PMC40M-GE-RFB
• Company DUNS: 058614483
• Company Name: Covidien LP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up (refer to IFU)
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 11 KiloPascal and 108 KiloPascal
• Handling Environment Atmospheric Pressure: Between 100 Millimeter of Mercury and 150 Millimeter of Mercury
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up (refer to IFU)
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 11 KiloPascal and 108 KiloPascal
• Handling Environment Atmospheric Pressure: Between 100 Millimeter of Mercury and 150 Millimeter of Mercury
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up (refer to IFU)
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 11 KiloPascal and 108 KiloPascal
• Handling Environment Atmospheric Pressure: Between 100 Millimeter of Mercury and 150 Millimeter of Mercury
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up (refer to IFU)
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 11 KiloPascal and 108 KiloPascal
• Handling Environment Atmospheric Pressure: Between 100 Millimeter of Mercury and 150 Millimeter of Mercury
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up (refer to IFU)
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 11 KiloPascal and 108 KiloPascal
• Handling Environment Atmospheric Pressure: Between 100 Millimeter of Mercury and 150 Millimeter of Mercury
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up (refer to IFU)
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 11 KiloPascal and 108 KiloPascal
• Handling Environment Atmospheric Pressure: Between 100 Millimeter of Mercury and 150 Millimeter of Mercury
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up (refer to IFU)
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 11 KiloPascal and 108 KiloPascal
• Handling Environment Atmospheric Pressure: Between 100 Millimeter of Mercury and 150 Millimeter of Mercury
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up (refer to IFU)
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 11 KiloPascal and 108 KiloPascal
• Handling Environment Atmospheric Pressure: Between 100 Millimeter of Mercury and 150 Millimeter of Mercury
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up (refer to IFU)
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 11 KiloPascal and 108 KiloPascal
• Handling Environment Atmospheric Pressure: Between 100 Millimeter of Mercury and 150 Millimeter of Mercury
• Handling Environment Atmospheric Pressure: Between 100 Millimeter of Mercury and 150 Millimeter of Mercury
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 11 KiloPascal and 108 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up (refer to IFU)
• Handling Environment Atmospheric Pressure: Between 100 Millimeter of Mercury and 150 Millimeter of Mercury
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 11 KiloPascal and 108 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up (refer to IFU)
• Handling Environment Atmospheric Pressure: Between 100 Millimeter of Mercury and 150 Millimeter of Mercury
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 11 KiloPascal and 108 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up (refer to IFU)
• Handling Environment Atmospheric Pressure: Between 100 Millimeter of Mercury and 150 Millimeter of Mercury
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 11 KiloPascal and 108 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up (refer to IFU)
• Handling Environment Atmospheric Pressure: Between 100 Millimeter of Mercury and 150 Millimeter of Mercury
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 11 KiloPascal and 108 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up (refer to IFU)
• Handling Environment Atmospheric Pressure: Between 100 Millimeter of Mercury and 150 Millimeter of Mercury
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 11 KiloPascal and 108 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up (refer to IFU)
• Handling Environment Atmospheric Pressure: Between 100 Millimeter of Mercury and 150 Millimeter of Mercury
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 11 KiloPascal and 108 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up (refer to IFU)
• Handling Environment Atmospheric Pressure: Between 100 Millimeter of Mercury and 150 Millimeter of Mercury
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 11 KiloPascal and 108 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up (refer to IFU)
• Handling Environment Atmospheric Pressure: Between 100 Millimeter of Mercury and 150 Millimeter of Mercury
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 11 KiloPascal and 108 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up (refer to IFU)
• Handling Environment Atmospheric Pressure: Between 100 Millimeter of Mercury and 150 Millimeter of Mercury
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 11 KiloPascal and 108 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up (refer to IFU)
• Handling Environment Atmospheric Pressure: Between 100 Millimeter of Mercury and 150 Millimeter of Mercury
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 11 KiloPascal and 108 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up (refer to IFU)
• Handling Environment Atmospheric Pressure: Between 100 Millimeter of Mercury and 150 Millimeter of Mercury
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 11 KiloPascal and 108 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up (refer to IFU)
• Handling Environment Atmospheric Pressure: Between 100 Millimeter of Mercury and 150 Millimeter of Mercury
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 11 KiloPascal and 108 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up (refer to IFU)
• Handling Environment Atmospheric Pressure: Between 100 Millimeter of Mercury and 150 Millimeter of Mercury
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 11 KiloPascal and 108 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up (refer to IFU)
• Handling Environment Atmospheric Pressure: Between 100 Millimeter of Mercury and 150 Millimeter of Mercury
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 11 KiloPascal and 108 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up (refer to IFU)
• Handling Environment Atmospheric Pressure: Between 100 Millimeter of Mercury and 150 Millimeter of Mercury
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 11 KiloPascal and 108 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up (refer to IFU)
• Handling Environment Atmospheric Pressure: Between 100 Millimeter of Mercury and 150 Millimeter of Mercury
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 11 KiloPascal and 108 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up (refer to IFU)

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521819023 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213518

FDA Product Code

• CCK: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-25
• Device Publish Date: 2022-07-16

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