FDA.reportPublic FDA data

Jaeger

Primary DI
04250892907345
Brand
Jaeger
Company
Jaeger Medical GmbH
Model
3.30
Catalog number
V-770968
Device description
SentrySuite Software
Published
2025-10-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZCCalculator, Pulmonary Function Data

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150810000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150810000Vyntus / SentrySuite Product LineCarefusion Germany 234 GmbH2015-08-14BZC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250892907345PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250892907345042508929073454250892907345

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary function analysis software, non-interpretiveA software program intended to be used on a non-medical computerized device for use by a healthcare professional to aid analysis of data captured during pulmonary function testing/analysis (e.g., spirometry, plethysmography, carbon dioxide breath analysis). It is intended to produce charts, graphs, and store data; it is not intended to interpret results. It is not intended for respiratory sound analysis.

Contacts#

Phone, Email table
PhoneEmail
+499314972127techsupport.int@jaegerrdx.com

Regulatory Flags#

DUNS number
329769991
Device count
1
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
04250892907352SentrySuite SoftwareJaeger Medical GmbHBZC2025-11-24
04250892908700JaegerJaeger Medical GmbHBZC2025-11-24
04250892908717JaegerJaeger Medical GmbHBZC2025-11-24
04250892908731JaegerJaeger Medical GmbHBZC2025-11-24
04250892908816JaegerJaeger Medical GmbHBZC2025-11-24
04250892908823JaegerJaeger Medical GmbHBZC2025-11-24
04250892908861JaegerJaeger Medical GmbHBZC2025-11-24
04250892908984JaegerJaeger Medical GmbHBZC2025-11-24
04250892908991JaegerJaeger Medical GmbHBZC2025-11-24
14250892908905JaegerJaeger Medical GmbHBZC2025-11-24
14250892908936JaegerJaeger Medical GmbHBZC2025-11-24
34250892909012JaegerJaeger Medical GmbHBZC2025-11-24
34250892909029JaegerJaeger Medical GmbHBZC2025-11-24
34250892908367JaegerJaeger Medical GmbHBZC2025-10-31
34250892908541JaegerJaeger Medical GmbHBZC2025-10-31
34250892908589JaegerJaeger Medical GmbHBZC2025-10-31
04250892908304JaegerJaeger Medical GmbHBZC2025-10-31
04250892908311JaegerJaeger Medical GmbHBZC2025-10-31
04250892908328JaegerJaeger Medical GmbHBZC2025-10-31
04250892908427JaegerJaeger Medical GmbHBZC2025-10-31
04250892908779JaegerJaeger Medical GmbHBZC2025-10-31
04250892908786JaegerJaeger Medical GmbHBZC2025-10-31
04250892908793JaegerJaeger Medical GmbHBZC2025-10-31
04250892908809JaegerJaeger Medical GmbHBZC2025-10-31
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