FDA.reportPublic FDA data

AVEA

Primary DI
10846446011913
Brand
AVEA
Company
VYAIRE MEDICAL, INC.
Model
16179
Catalog number
16179
Device description
BATTERY, 2 PACK, AVEA
Published
2021-05-07
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
K103211000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103211000AVEA VENTILATORCare Fusion2011-05-12CBK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10846446011913PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084644601191310846446011913

GMDN Terms#

Term, Definition table
TermDefinition
Uninterruptible power supplyA portable device, commonly known as an uninterruptible power supply (UPS), designed to provide a continuous supply of electrical power for a limited period of time to a connected device or devices during the failure of the mains electricity (AC-power) supply due to an emergency situation, e.g., a blackout, or maintenance/testing. It will contain its own set of batteries that normally maintain their charge from the mains power supply and it is these that provide the power when a failure in the line-power occurs. This device is used locally (at the point of use) and is often reserved to supply vital devices, e.g., ventilators, patient monitoring devices and computer dependent devices.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(833)327-3284customersupport@vyaire.com

Regulatory Flags#

DUNS number
080456871
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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10190752115200AirLife™0020030020032020-01-15
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10190752153158VELA11571115712021-03-29
10190752114814AirLife™0024320024322020-01-15
10190752114821AirLife™ Misty Max 10™ Nebulizer With 7 foot (2.1 m) 0024330024332020-01-15
10190752114838AirLife™0024340024342020-01-15
10190752114845AirLife™0024350024352020-01-15
10190752114852AirLife™0024370024372020-01-15
10190752114869AirLife™0024380024382020-01-15
10190752114876AirLife™0024390024392020-01-15
10190752114883AirLife™0024400024402021-04-02
10190752114890AirLife™0024420024422020-01-15
10190752114906AirLife™0024430024432020-01-15
10190752114913AirLife™0024440024442020-01-15
10190752114920AirLife™0024450024452020-01-15
10190752114937AirLife™0024460024462020-01-15
10190752114944AirLife™0024500024502020-01-15
10190752114968AirLife™0024580024582020-01-15

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Primary DI, Brand, Company table
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00814747025284Novaplus Full Face Non Vented Mask, LargeSLEEPNET, CORP.CBK2026-10-23
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