Newport

GUDID 10884521542334

LW AIR/O2 MIX W/GRNHS, DISS FT

Covidien LP

Neonatal/adult intensive-care ventilator

• Primary Device ID: 10884521542334
• NIH Device Record Key: 886f96b6-b10b-463b-bc14-dca80a3a1745
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Newport
• Version Model Number: MXL70A-GR-DS
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521542334 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K860373

FDA Product Code

• BZR: Mixer, breathing gases, anesthesia inhalation

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-11-08
• Device Publish Date: 2018-09-22

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• 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