FDA.reportPublic FDA data

EVOLUTION

Primary DI
B079EVL100500T1
Brand
EVOLUTION
Company
Event Medical, Ltd.
Model
T
Published
2020-08-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
B079EVL100500T1PrimaryHIBCC0

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
9499001917Customer.Service@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
00860008873606eVolution 3e VentilatoreVolution 3e Ventilator- Turbine EssentialEVL100500-T, EVL100500-T-NF2022-08-10
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00198843007352LTVZoll Medical CorporationCBK2026-09-18
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00198843002852bellavistaZoll Medical CorporationCBK2026-07-10
00198843002869bellavistaZoll Medical CorporationCBK2026-07-10
00198843002876bellavistaZoll Medical CorporationCBK2026-07-06
00198843001145bellavistaZoll Medical CorporationCBK2026-06-24
00198843001152bellavistaZoll Medical CorporationCBK2026-06-24
00848530108816Breathing CircuitSunset Healthcare Solutions, Inc.CBK2026-04-17
10197344102655MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
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08056814676223DIMARHMC PREMEDICAL SPACBK2025-03-20
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