Newport E360TH-ES-NA

GUDID 10884521510784

E360T VENT, TS HEAD ONLY,SPAN

Newport Medical Instruments, Inc.

Neonatal/adult intensive-care ventilator

• Primary Device ID: 10884521510784
• NIH Device Record Key: 31408c50-d15a-443c-8f54-22a4ca7acd1a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Newport
• Version Model Number: E360TH-ES-NA
• Catalog Number: E360TH-ES-NA
• Company DUNS: 050334275
• Company Name: Newport Medical Instruments, Inc.
• 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
• 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

• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521510784 [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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-08-14
• Device Publish Date: 2018-01-31

On-Brand Devices [Newport]

• 10884521541306: e360 Ventilator with Accessories;T Model
• 10884521541207: e360 Ventilator with Accessories;T Model
• 10884521541191: e360 Ventilator with Accessories;T Model
• 10884521541115: e360 Ventilator with Accessories;S Model
• 10884521541085: e360 Ventilator with Accessories;S Model
• 10884521510791: e360 Ventilator with Accessories T Model
• 10884521541290: e360 Ventilator with Accessories;T Model
• 10884521541276: e360 Ventilator with Accessories;T Model
• 10884521541177: e360 Ventilator with Accessories;T Model
• 10884521540934: e360 Ventilator with Accessories;E Model
• 10884521540927: e360 Ventilator with Accessories;E Model
• 10884521541139: e360 Ventilator with Accessories;S Model
• 10884521510821: e360 Ventilator with Accessories T Model
• 10884521212183: e360 Ventilator with Accessories S Model
• 10884521510845: e360 Ventilator with Accessories T Model
• 10884521542259: HT70 Ventilator With Accessories;Plus Model
• 10884521541245: e360 Ventilator with Accessories;T Model
• 10884521510760: e360 Ventilator with Accessories S Model
• 10884521542143: HT70 Ventilator With Accessories;O2 Monitor
• 10884521544062: HT70 Ventilator with Accessories O2 Monitor
• 10884521544345: HT70 Ventilator with Accessories
• 10884521542211: HT70 Ventilator With Accessories;Plus Model
• 10884521541269: e360 Ventilator with Accessories;T Model
• 10884521541252: e360T VENTILATOR, T MODEL US, HEAD ONLY NA POWER
• 10884521541214: e360 Ventilator with Accessories;T Model
• 10884521541184: e360 Ventilator with Accessories;T Model
• 10884521541146: e360 Ventilator with Accessories;S Model
• 10884521541122: e360 Ventilator with Accessories;S Model
• 10884521541023: e360 VENTILATOR, SPANISH PLUS
• 10884521510784: E360T VENT, TS HEAD ONLY,SPAN
• 10884521510623: E360T VENT,TS HEAD ONLY, CHIN
• 10884521510593: E360T1 VENTILATOR BRAZIL, EXPANDED TOUCH HEAD ONLY
• 10884521541238: e360 Ventilator with Accessories;T Model
• 10884521544369: HT70 Ventilator with Accessories Plus Model
• 10884521544321: HT70 Ventilator with Accessories Plus Model
• 10884521542228: HT70 Ventilator With Accessories;Plus Model
• 10884521542198: HT70 Ventilator With Accessories;Plus Model
• 10884521510869: e360 Ventilator with Accessories T Model
• 10884521511279: e360 Ventilator with Accessories E Model
• 10884521544413: HT70 Ventilator with Accessories Plus Model
• 10884521542266: HT70 Ventilator With Accessories Plus Model
• 10884521542242: HT70 Ventilator With Accessories Plus Model
• 10884521542235: HT70 Ventilator With Accessories Plus Model
• 10884521542204: HT70 Ventilator With Accessories Plus Model
• 10884521542181: HT70 Ventilator With Accessories Plus Model
• 10884521542174: HT70 Ventilator With Accessories Plus Model
• 10884521511774: e360 Ventilator with Accessories T Model
• 10884521208940: HT70PLUS VENT,ENGLISH,NA CORDD, D/L
• 10884521541283: e360 Ventilator with Accessories;T Model
• 10884521541009: e360 Ventilator with Accessories;E Model