AccessGUDID - DEVICE: eVolution 3e Ventilator (00860008873606)

GUDID

Device Identifier (DI) Information

Brand Name: eVolution 3e Ventilator
Version or Model: eVolution 3e Ventilator- Turbine Essential
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EVL100500-T, EVL100500-T-NF
Company Name: Event Medical, Ltd.

Primary DI Number: 00860008873606
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 791890861 *Terms of Use

Device Description: eVolution 3e Ventilator System

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):	Yes
Over the Counter (OTC):	No
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?
47244	General-purpose intensive-care ventilator	A mains electricity (AC-powered) automatic cycling device intended to provide long-term alveolar ventilation support for a patient, excluding neonates or small infants, in various clinical uses. 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 [?]
K113743	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ae012c69-20ca-4502-8a52-67b0bdb68444
Public Version Date: August 18, 2022
Public Version Number: 1
DI Record Publish Date: August 10, 2022