Capnostream20p

GUDID 10884521771703

Portable Bedside Capnography Demo Loaner

ORIDION MEDICAL 1987 LTD.

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• Primary Device ID: 10884521771703
• NIH Device Record Key: c8c99891-3e45-46f0-aea7-69fdc5c212b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Capnostream20p
• Version Model Number: DLCS08652-03
• Company DUNS: 600111512
• Company Name: ORIDION MEDICAL 1987 LTD.
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• 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

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 430 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 430 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 430 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 430 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 430 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 430 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 430 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 430 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 430 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 430 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 430 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 430 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 430 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 430 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 430 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 430 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 430 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521771703 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123690

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: 2021-11-19
• Device Publish Date: 2021-11-11

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