FDA.reportPublic FDA data

Jaeger

Primary DI
04250892900827
Brand
Jaeger
Company
Vyaire Medical GmbH
Model
V-178001-13
Catalog number
V-178001-13
Device description
Vyntus CPX
Published
2016-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZCCalculator, Pulmonary Function Data

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250892900827PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250892900827042508929008274250892900827

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+499314972127support.rt.eu.jae@carefusion.c
+499314972127support.rt.eu.jae@carefusion.com

Regulatory Flags#

DUNS number
329769991
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14250892906833Vyaire36-NPROBE0136-NPROBE012025-01-07
14250892906840Vyaire36-NPROBE0236-NPROBE022025-01-07
14250892906857Vyaire36-NPROBE0336-NPROBE032025-01-07
14250892906864Vyaire36-NPROBE0436-NPROBE042025-01-07
04250892905945Vyaire3.30V-7709682024-03-25
04250892905211MasterScreenV-175422V-1754222021-04-09
04250892905228MasterScreenV-175428V-1754282021-04-09
14250892906543Vyaire36-MLD162136-MLD16212021-11-16
14250892906550Vyaire36-TDX104336-TDX10432021-11-16
04250892906645Vyaire7203207203202021-11-15
14250892906499Vyaire7072387072382021-11-15
14250892906529Vyaire7072257072252021-11-15
14250892906536Vyaire7072307072302021-11-15
14250892906567Vyaire36-TDX105136-TDX10512021-11-15
14250892906574Vyaire36-TDX104836-TDX10482021-11-15
14250892906635Vyaire36-TDX105036-TDX10502021-11-15
14250892906659Vyaire7110077110072021-11-15
14250892906680Vyaire36-MFA105036-MFA10502021-09-24
14250892906697Vyaire36-MFA101036-MFA10102021-09-24
14250892906703Vyaire36-ASS127036-ASS12702021-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250892907352SentrySuite SoftwareJaeger Medical GmbHBZC2025-11-24
04250892908700JaegerJaeger Medical GmbHBZC2025-11-24
04250892908717JaegerJaeger Medical GmbHBZC2025-11-24
04250892908731JaegerJaeger Medical GmbHBZC2025-11-24
04250892908823JaegerJaeger Medical GmbHBZC2025-11-24
04250892908861JaegerJaeger Medical GmbHBZC2025-11-24
04250892908984JaegerJaeger Medical GmbHBZC2025-11-24
04250892908991JaegerJaeger Medical GmbHBZC2025-11-24
14250892908936JaegerJaeger Medical GmbHBZC2025-11-24
34250892909012JaegerJaeger Medical GmbHBZC2025-11-24
34250892909029JaegerJaeger Medical GmbHBZC2025-11-24
14250892907335JaegerJaeger Medical GmbHBZC2025-08-21
34250892908169JaegerJaeger Medical GmbHBZC2025-08-18
34250892908176JaegerJaeger Medical GmbHBZC2025-08-18
34250892908190JaegerJaeger Medical GmbHBZC2025-08-18
34250892908220JaegerJaeger Medical GmbHBZC2025-08-18
34250892908237JaegerJaeger Medical GmbHBZC2025-08-18
34250892907032JaegerJaeger Medical GmbHBZC2025-08-14
34250892907070JaegerJaeger Medical GmbHBZC2025-08-14
14250892909117JaegerJaeger Medical GmbHBZC2025-08-11
14250892909100JaegerJaeger Medical GmbHBZC2025-08-08
14250892907670JaegerJaeger Medical GmbHBZC2025-07-29
14250892907687JaegerJaeger Medical GmbHBZC2025-07-29
14250892907694JaegerJaeger Medical GmbHBZC2025-07-29
14250892907700JaegerJaeger Medical GmbHBZC2025-07-29
14250892907717JaegerJaeger Medical GmbHBZC2025-07-29
14250892907724JaegerJaeger Medical GmbHBZC2025-07-29
14250892907731JaegerJaeger Medical GmbHBZC2025-07-29
14250892907755JaegerJaeger Medical GmbHBZC2025-07-29
14250892907830JaegerJaeger Medical GmbHBZC2025-07-29