FDA.reportPublic FDA data

Jaeger

Primary DI
04250892908427
Brand
Jaeger
Company
Jaeger Medical GmbH
Model
v-178001-13
Catalog number
v-178001-13
Device description
Vyntus CPX
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
MLCMonitor, St Segment
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZCCalculator, Pulmonary Function DataAnesthesiology2
DPSElectrocardiographCardiovascular2
MLCMonitor, St SegmentCardiovascular2
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183567000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183567000Vyntus/SentrySuite Product LineVyaire Medical2019-08-23BZC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250892908427PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250892908427042508929084274250892908427

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary stress exercise monitoring systemAn assembly of devices intended to noninvasively assess the cardiopulmonary response to exercise or measure of energy expenditure using indirect calorimetry. Breath by breath measurements of flow, oxygen (O2) uptake, and carbon dioxide (CO2) production are performed by O2 and CO2 analysers during exercise, along with the measurement of vital parameters. A mask, mouthpiece, or hood is attached to tubing and connected from the patient to the gas analysers while exercise is being performed using a particular device (e.g., an ergometer). The system typically monitors functions [e.g., provides continuous electrocardiogram (ECG)], provides control of the workload, and displays and prints results.

Storage And Handling#

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

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
08719689142124QMAPP Fysicon B.V.MWI2026-05-19
08719689142131QMAPP Fysicon B.V.MWI2026-05-19
08719689142162QMAPP Fysicon B.V.MWI2026-05-19
08719689142179QMAPP Fysicon B.V.MWI2026-05-19
10197344213245MEDLINEMEDLINE INDUSTRIES, INC.MWI2026-05-08
10197344213252MEDLINEMEDLINE INDUSTRIES, INC.MWI2026-05-08
10197344213238MEDLINEMEDLINE INDUSTRIES, INC.MWI2026-04-23
B153300010AirStrip ONE PlatformAirstrip Technologies, Inc.MWI2026-03-18
B153301010AirStrip ONE Client iOSAirstrip Technologies, Inc.MWI2026-03-18
B153301020AirStrip ONE Client AndroidAirstrip Technologies, Inc.MWI2026-03-18
10884838113777MR Patient Care Adult SpO2 ClipPhilips Medizin Systeme Böblingen GmbHMWI2026-03-16
10884838115092MR Patient Care Pediatric SpO2 ClipPhilips Medizin Systeme Böblingen GmbHMWI2026-03-16
17540262100143Change Healthcare Cardiology HemoChange Healthcare Canada CompanyMWI2026-03-09
17540262170047Change Healthcare Cardiology HemodynamicsChange Healthcare Canada CompanyMWI2026-03-09
10843997011003Radius VSMMASIMO CORPORATIONDPS2026-02-23
10843997016015Radius VSMMASIMO CORPORATIONDPS2026-02-23
10884838129938MR Patient Care Temperature Sensor JacketPhilips Medizin Systeme Böblingen GmbHMWI2026-01-06
14250892908509JaegerJaeger Medical GmbHMWI2025-11-24
14250892908509JaegerJaeger Medical GmbHMLC2025-11-24
14250892908509JaegerJaeger Medical GmbHDPS2025-11-24
14250892908905JaegerJaeger Medical GmbHBZC2025-11-24
14250892908936JaegerJaeger Medical GmbHMLC2025-11-24
14250892908936JaegerJaeger Medical GmbHMWI2025-11-24
14250892908936JaegerJaeger Medical GmbHDPS2025-11-24
34250892909012JaegerJaeger Medical GmbHMLC2025-11-24
34250892909012JaegerJaeger Medical GmbHMWI2025-11-24
34250892909012JaegerJaeger Medical GmbHDPS2025-11-24
34250892909029JaegerJaeger Medical GmbHMWI2025-11-24
34250892909029JaegerJaeger Medical GmbHMLC2025-11-24
34250892909029JaegerJaeger Medical GmbHDPS2025-11-24