FDA.reportPublic FDA data

Jaeger

Primary DI
34250892908367
Brand
Jaeger
Company
Jaeger Medical GmbH
Model
V-707277
Catalog number
V-707277
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
34250892908367PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3425089290836734250892908367

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiograph, professional, multichannelA device intended to be used by a healthcare professional in a clinical setting to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed for recording the electrical signal from two or more configurations of electrodes (ECG-leads) at a time (multichannel) and may be intended for resting ECG and/or stress/exercise ECG. It will either include an integrated display or be designed to transmit ECG data to an off-the-shelf device for display; ECG electrodes may be included. Data interpretation and/or telemetry features might also be included.

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

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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 GmbHMWI2025-11-24
34250892909012JaegerJaeger Medical GmbHMLC2025-11-24
34250892909012JaegerJaeger Medical GmbHDPS2025-11-24
34250892909029JaegerJaeger Medical GmbHMWI2025-11-24
34250892909029JaegerJaeger Medical GmbHMLC2025-11-24
34250892909029JaegerJaeger Medical GmbHDPS2025-11-24