AccessGUDID - DEVICE: Newport (10884521541047)

GUDID

Device Identifier (DI) Information

Brand Name: Newport
Version or Model: E360P-SY-NA
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: E360P-SY-NA
Company Name: Covidien LP

Primary DI Number: 10884521541047
Issuing Agency: GS1
Commercial Distribution End Date: October 27, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 058614483 *Terms of Use

Device Description: e360 Ventilator with Accessories;E Model

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
42411	Neonatal/adult intensive-care ventilator	A mains electricity (AC-powered) automatic cycling device intended to provide long-term alveolar ventilation support for the full age-range of patients, from neonatal, paediatric to adult, in a critical care setting. It typically uses positive pressure to deliver gas at normal breathing rates and tidal volumes through an endotracheal (ET) tube or tracheostomy, and consists of a breathing circuit, a control system, monitors, and alarms. The inhalation limb includes sites where inspired gas may be heated/humidified, and the exhalation limb includes an exhaust valve to release gas to the ambient air. It can be operated in several modes (e.g., assist/control, synchronized, patient triggered).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CBK	VENTILATOR, CONTINUOUS, FACILITY USE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between 5 and 40 Degrees Celsius
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Humidity: between 0 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ea1b36c8-b9e4-41df-a7db-64193dc6f351
Public Version Date: June 13, 2025
Public Version Number: 5
DI Record Publish Date: October 22, 2015