Newport DLE360S-US-NA

GUDID 10884521208971

D/L, e360S Vent, UD

Covidien LP

Neonatal/adult intensive-care ventilator

• Primary Device ID: 10884521208971
• NIH Device Record Key: befc843c-3bc1-4cba-a7f8-8f79c443978e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Newport
• Version Model Number: DLE360S-US-NA
• Catalog Number: DLE360S-US-NA
• Company DUNS: 058614483
• Company Name: Covidien LP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: true

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

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *No
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, Stacking limitations, This side up
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, Stacking limitations, This side up
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, Stacking limitations, This side up
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, Stacking limitations, This side up
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, Stacking limitations, This side up
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, Stacking limitations, This side up
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, Stacking limitations, This side up
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, Stacking limitations, This side up
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, Stacking limitations, This side up
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, Stacking limitations, This side up
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, Stacking limitations, This side up
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, Stacking limitations, This side up
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, Stacking limitations, This side up
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, Stacking limitations, This side up
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, Stacking limitations, This side up
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, Stacking limitations, This side up
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, Stacking limitations, This side up
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521208971 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101803

FDA Product Code

• CBK: VENTILATOR, CONTINUOUS, FACILITY USE

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: 2019-04-15
• Device Publish Date: 2019-04-07

On-Brand Devices [Newport]

• 10884521208971: D/L, e360S Vent, UD
• 10884521541108: e360 Ventilator with Accessories;S Model
• 10884521208957: E360T VENT, TS, US DEMO LOANER
• 10884521774049: PED/Adult Airway Flow Sensor
• 10884521208988: D/L, HT50-H1-B Vent
• 10884521650169: LT/WT Oxy Mixer w/ISO Green Conductive Hose
• 10884521542334: LW AIR/O2 MIX W/GRNHS, DISS FT
• 10884521541078: e360 VENTILATOR, S MODEL CHINESE NA POWER
• 10884521541030: e360 Ventilator with Accessories;E Model
• 10884521541047: e360 Ventilator with Accessories;E Model
• 10884521540910: e36O VENTILATOR, E MODEL CHINESE NA POWER
• 10884521541221: e360 VENTILATOR, TH MODEL CHINESE, HEAD ONLY, NA POWER