FDA.reportPublic FDA data

Vyaire

Primary DI
04250892905679
Brand
Vyaire
Company
Jaeger Medical GmbH
Model
706570
Catalog number
706570
Device description
Isolation - Transformer
Published
2019-05-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K981366000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K981366000STATIC AND DYNAMIC COMPLIANCE, A RESPIRATORY MECHANICS OPTION FOR THE VMAX SERIESSensor Medics Corp.1998-10-30BTY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250892905679PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250892905679042508929056794250892905679

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
+499314972127support.rt.eu@vyaire.com

Regulatory Flags#

DUNS number
329769991
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250892907352SentrySuite Software3.20V-7709652025-11-24
04250892908700Jaeger375119-13375119-132025-11-24
04250892908717Jaeger7066967066962025-11-24
04250892908731JaegerV-176420-13V-176420-132025-11-24
04250892908816Jaeger705560N705560N2025-11-24
04250892908823JaegerV-707525V-7075252025-11-24
04250892908861JaegerV-171470-13V-171470-132025-11-24
04250892908984JaegerV-577400-13V-577400-132025-11-24
04250892908991JaegerV-577084-13V-577084-132025-11-24
04250892909004Jaeger5.7V-770868-132025-11-24
04250892909059Jaeger28-835809-0012025-11-24
04250892909066Jaeger28-4b23795-0012025-11-24
14250892907243Jaeger36-NPROBETU2025-11-24
14250892907250Jaeger36-NPROBE0136-NPROBE012025-11-24
14250892907267Jaeger36-NPROBE0236-NPROBE022025-11-24
14250892907274Jaeger36-NPROBE0336-NPROBE032025-11-24
14250892907281Jaeger36-NPROBE0436-NPROBE042025-11-24
14250892908509Jaeger36-TDX105036-TDX10502025-11-24
14250892908905JaegerV-707183V-7071832025-11-24
14250892908929Jaeger36-PSA180036-PSA18002025-11-24

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