FDA.reportPublic FDA data

Vela

Primary DI
10846446063912
Brand
Vela
Company
Carefusion Corporation
Model
11540-PMN
Catalog number
11540-PMN
Device description
Stand Assy, Transport
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
10846446063912PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084644606391210846446063912

GMDN Terms#

Term, Definition table
TermDefinition
Transportable medical equipment stand, non-poweredA non-powered (non-active) transportable device [e.g., on wheels or easily movable] designed to support medical equipment used for clinical purposes [e.g., in an operating room and/or an examination/treatment room]. It may include manually-adjustable articulated arms to enable dynamic positioning of equipment; the equipment to be supported is not included. The device does not include a battery pack but might include a battery holder and electrical connection wiring to feed power to medical equipment.

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
Manufacturing date on label
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
Primary DIBrandCompanyProduct codePublished
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00198843002852bellavistaZoll Medical CorporationCBK2026-07-10
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00198843002876bellavistaZoll Medical CorporationCBK2026-07-06
00198843001145bellavistaZoll Medical CorporationCBK2026-06-24
00198843001152bellavistaZoll Medical CorporationCBK2026-06-24
10197344102655MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102662MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102679MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102686MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102693MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102709MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
09420012477477F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012477484F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012477491F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480446F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480460F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480484F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
08056814676223DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676247DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676254DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676261DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676377DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676384DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676391DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676407DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676360DIMARHMC PREMEDICAL SPACBK2025-03-20
10889483603987AirLife™AIRLIFECBK2025-02-26
10889483603994AirLife™AIRLIFECBK2025-02-26