FDA.reportPublic FDA data

eVolution 3e Ventilator

Primary DI
00860008873606
Brand
eVolution 3e Ventilator
Company
Event Medical, Ltd.
Model
eVolution 3e Ventilator- Turbine Essential
Catalog number
EVL100500-T, EVL100500-T-NF
Device description
eVolution 3e Ventilator System
Published
2022-08-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CBKVentilator, Continuous, Facility Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBKVentilator, Continuous, Facility UseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113743000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113743000EVOLUTION 3E VENTILATOREvent Medical, Inc.2012-12-18CBK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860008873606PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008873606008600088736068600088736060860008873606

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose intensive-care ventilatorA 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).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
19499001917a.hedayati@event-medical.com

Regulatory Flags#

DUNS number
791890861
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860008873637INSPIRATION 7i Ventilator "INSPIRATION 7i Ventilator 17"" screen "F7300000-7i-F, F7300000-7i-L2022-07-29
B079EVL100500T1EVOLUTIONT2020-08-20
B079EVM11000101US0Inspiration 7i Ventilator SystemInspiration Ventilator SystemF7300000-7i-L-US2015-11-19
B079EVM11000102US0Inspiration 7i Ventilator SystemInspiration Ventilator SystemF7300000-7i-S-US2015-11-19
B079EVM11000103US0Inspiration 7i Ventilator SystemInspiration Ventilator SystemF7300000-7i-F-US2015-11-19

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