186-0150-PH

GUDID 10884521134324

Sensor Quatro Start-Up Kit

Covidien LP

Single-patient intensive/general healthcare physiologic monitoring system

• Primary Device ID: 10884521134324
• NIH Device Record Key: 6a5ddc97-131e-4182-bf5d-772bba2fad13
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 186-0150-PH
• Catalog Number: 186-0150-PH
• Company DUNS: 058614483
• Company Name: Covidien LP
• Device Count: 5
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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
• 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
• 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 Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep Dry, This side up
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep Dry, This side up
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep Dry, This side up
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep Dry, This side up
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep Dry, This side up
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep Dry, This side up
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep Dry, This side up
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep Dry, This side up
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep Dry, This side up
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep Dry, This side up
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep Dry, This side up
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep Dry, This side up
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep Dry, This side up
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep Dry, This side up
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep Dry, This side up
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep Dry, This side up
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep Dry, This side up
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep Dry, This side up
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep Dry, This side up
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep Dry, This side up
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep Dry, This side up
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep Dry, This side up
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep Dry, This side up
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep Dry, This side up
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep Dry, This side up
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep Dry, This side up
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep Dry, This side up
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep Dry, This side up
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep Dry, This side up
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep Dry, This side up
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep Dry, This side up
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep Dry, This side up
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep Dry, This side up
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep Dry, This side up
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep Dry, This side up
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep Dry, This side up
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep Dry, This side up
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep Dry, This side up
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep Dry, This side up
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep Dry, This side up
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep Dry, This side up
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep Dry, This side up
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep Dry, This side up
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep Dry, This side up
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521134324 [Primary]
GS1	20884521134321 [Unit of Use]
GS1	20884521657820 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093183

FDA Product Code

• GXY: ELECTRODE, CUTANEOUS

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-06
• Device Publish Date: 2016-10-13

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