FDA.reportPublic FDA data

Jaeger

Primary DI
04250892908809
Brand
Jaeger
Company
Jaeger Medical GmbH
Model
V-178603
Catalog number
V-178603
Device description
Vyntus ONE
Published
2025-10-31
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
BZCCalculator, Pulmonary Function Data
DPSElectrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZCCalculator, Pulmonary Function DataAnesthesiology2
DPSElectrocardiographCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181524000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181524000Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CARTVyaire Medical, Inc.2018-11-30BZC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250892908809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250892908809042508929088094250892908809

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].

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+499314972127techsupport.int@jaegerrdx.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
00810209880019CORE 500 Digital Stethoscope FIGS Earpiece - Rapid Response PinkEko Devices, Inc.DPS2026-04-03
00810209880026CORE 500 Digital Stethoscope FIGS Earpiece - Orange TaffyEko Devices, Inc.DPS2026-04-03
00195278620873MACGe Medical Systems Information Technologies, Inc.DPS2026-03-31
10843997011003Radius VSMMASIMO CORPORATIONDPS2026-02-23
10843997016015Radius VSMMASIMO CORPORATIONDPS2026-02-23
00810209880002CORE 500 Digital Stethoscope FIGS Earpiece - Caribbean BlueEko Devices, Inc.DPS2026-01-29
00810209880040EFAST (Eko Foundation Analysis Software with Transformers)Eko Devices, Inc.DPS2026-01-29
14250892908509JaegerJaeger Medical GmbHDPS2025-11-24
14250892908905JaegerJaeger Medical GmbHBZC2025-11-24
14250892908936JaegerJaeger Medical GmbHDPS2025-11-24
34250892909012JaegerJaeger Medical GmbHDPS2025-11-24
34250892909029JaegerJaeger Medical GmbHDPS2025-11-24
34250892908367JaegerJaeger Medical GmbHBZC2025-10-31
34250892908367JaegerJaeger Medical GmbHDPS2025-10-31
34250892908541JaegerJaeger Medical GmbHDPS2025-10-31
34250892908541JaegerJaeger Medical GmbHBZC2025-10-31
34250892908589JaegerJaeger Medical GmbHBZC2025-10-31
34250892908589JaegerJaeger Medical GmbHDPS2025-10-31
14250892907045JaegerJaeger Medical GmbHBZC2025-08-14
14250892907052JaegerJaeger Medical GmbHBZC2025-08-14
14250892907069JaegerJaeger Medical GmbHBZC2025-08-14
34250892907032JaegerJaeger Medical GmbHDPS2025-08-14
34250892907070JaegerJaeger Medical GmbHDPS2025-08-14
14250892909100JaegerJaeger Medical GmbHDPS2025-08-08
14250892907625JaegerJaeger Medical GmbHDPS2025-07-24
14250892907519JaegerJaeger Medical GmbHBZC2025-07-23
14250892907649JaegerJaeger Medical GmbHDPS2025-07-17
14250892908042JaegerJaeger Medical GmbHDPS2025-07-17
14250892907489JaegerJaeger Medical GmbHDPS2025-06-06
14250892907632JaegerJaeger Medical GmbHDPS2025-06-06