Inspiration 7i Ventilator System

Primary DI
B079EVM11000103US0
Brand
Inspiration 7i Ventilator System
Company
Event Medical, Ltd.
Model
Inspiration Ventilator System
Catalog number
F7300000-7i-F-US
Device description
"Inspiration Ventilator System, model 7i Flagship with 17"" Display Panel"
Published
2015-11-19
Public version status
Update
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
K130178000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130178000INSPIRATION VENTILATOR SYSTEM 5I/7IeVent Medical, Ltd.2013-10-29CBK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B079EVM11000103US0PrimaryHIBCC0

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
949-900-1917r.waters@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
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

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