FDA.reportPublic FDA data

Jaeger

Primary DI
34250892908589
Brand
Jaeger
Company
Jaeger Medical GmbH
Model
V-375610
Catalog number
V-375610
Device description
Vyntus ECG
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
34250892908589PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3425089290858934250892908589

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 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
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945700048020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945700048020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048030WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945700048030WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048040WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945700048040WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048050WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945700048050WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048060WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945700048060WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048070WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945700048070WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048080WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945700048080WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27