FDA.reportPublic FDA data

Vela

Primary DI
10846446005431
Brand
Vela
Company
Carefusion Corporation
Model
16532-01
Catalog number
16532-01
Device description
Vela Comprehensive Ventilator
Published
2017-05-01
Public version status
Update
Distribution status
Not 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
K093094000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093094000VELA VENTILATORCardinal Health 207, Inc.2010-05-11CBK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10846446005431PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084644600543110846446005431

GMDN Terms#

Term, Definition table
TermDefinition
Neonatal/adult intensive-care ventilatorA 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).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800.231.2466support.smcvent.us@carefusion.com

Regulatory Flags#

DUNS number
830432451
Device count
1
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885403006432AirLife0020060020062016-09-01
10885403011870AirLife9066-HS79066-HS72016-09-01
10885403026799AirLife10808-H1210808-H122016-09-01
10885403026850AirLife1212-H111212-H112016-09-01
10885403026881AirLife1704-H071704-H072016-09-01
10885403026959AirLife5753-H105753-H102016-09-01
10885403027024AirLife6463-H086463-H082016-09-01
10885403027055AirLife6814-H126814-H122016-09-01
10885403027116AirLife7102-HS77102-HS72016-09-01
10885403027130AirLife7104-HS77104-HS72016-09-01
10885403027154AirLife7142-HS77142-HS72016-09-01
10885403027185AirLife7149-HS77149-HS72016-09-01
10885403027260AirLife7418-HS37418-HS32016-09-01
10885403027314AirLife9037-HS79037-HS72016-09-01
10885403027390AirLife9061-HS79061-HS72016-09-01
10885403027420AirLife9064-HS79064-HS72016-09-01
10885403027444AirLife9065-HS79065-HS72016-09-01
10885403027451AirLife9073-HS79073-HS72016-09-01
10885403027581AirLifeRC6Y023034RC6Y0230342016-09-01
10885403027598AirLifeRT409-852RT409-8522016-09-01

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Primary DI, Brand, Company table
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