FDA.reportPublic FDA data

Vmax

Primary DI
10190752114029
Brand
Vmax
Company
VYAIRE MEDICAL, INC.
Model
28281-001
Catalog number
28281-001
Device description
SWR PKG CARDIOSOFT V6.73
Published
2021-07-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTYCALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTYCalculator, Predicted Values, Pulmonary FunctionAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K942211000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K942211000VMAX229 SERIES PULMONARY/METABOLIC SYSTEMSSensor Medics Corp.1994-11-22BTY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10190752114029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019075211402910190752114029

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary function analysis system, adultA device used to measure the function of the respiratory system in adults and compliant children. It usually includes a spirometer with volume-sensing (e.g., rolling-seal, bellow) and flow-sensing (e.g., pneumotachometer) devices, a gas analyser for evaluation of absolute lung volumes and gas-diffusing capacity of the lungs, and computer capabilities for data processing and recording; a total-body plethysmograph to measure both lung volumes and airway resistance may be included. The device is mostly used for outpatient or presurgical screening, and may also be used in the diagnosis and evaluation of common diseases in older children [e.g., asthma, cystic fibrosis (CF), chest deformities].

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
10190752129993LTV11581-G11581-G2021-02-22
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
10190752114975AirLife™0025010025012020-01-15
10190752114982AirLife™0025020025022020-01-15
10190752114999AirLife™0025300025302020-01-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
050991693321579100 VITALOGRAPH VitaloLAB+VITALOGRAPH (IRELAND) LIMITEDBTY2026-06-02
00850000967328SpiroLoopCMI HEALTH INC.BTY2026-03-06
00850000967625SpiroLink 2 ProCMI HEALTH INC.BTY2026-03-06
04250892908816JaegerJaeger Medical GmbHBTY2025-11-24
04250892908861JaegerJaeger Medical GmbHBTY2025-11-24
04250892909059JaegerJaeger Medical GmbHBTY2025-11-24
04250892909066JaegerJaeger Medical GmbHBTY2025-11-24
34250892908633JaegerJaeger Medical GmbHBTY2025-10-31
04250892908304JaegerJaeger Medical GmbHBTY2025-10-31
04250892908311JaegerJaeger Medical GmbHBTY2025-10-31
04250892908328JaegerJaeger Medical GmbHBTY2025-10-31
04250892908618JaegerJaeger Medical GmbHBTY2025-10-31
34250892908213JaegerJaeger Medical GmbHBTY2025-08-18
04057155000948ERT PTeResearchTechnology GmbHBTY2025-08-11
04057155000955ERT PTeResearchTechnology GmbHBTY2025-08-11
14250892909117JaegerJaeger Medical GmbHBTY2025-08-11
14250892907670JaegerJaeger Medical GmbHBTY2025-07-29
14250892907687JaegerJaeger Medical GmbHBTY2025-07-29
14250892907694JaegerJaeger Medical GmbHBTY2025-07-29
14250892907700JaegerJaeger Medical GmbHBTY2025-07-29
14250892907748JaegerJaeger Medical GmbHBTY2025-07-29
14250892907755JaegerJaeger Medical GmbHBTY2025-07-29
14250892907571JaegerJaeger Medical GmbHBTY2025-07-24
14250892907526JaegerJaeger Medical GmbHBTY2025-07-23
14250892907533JaegerJaeger Medical GmbHBTY2025-07-23
14250892907557JaegerJaeger Medical GmbHBTY2025-07-23
14250892907564JaegerJaeger Medical GmbHBTY2025-07-23
14250892907588JaegerJaeger Medical GmbHBTY2025-07-23
14250892907595JaegerJaeger Medical GmbHBTY2025-07-23
14250892907601JaegerJaeger Medical GmbHBTY2025-07-23