Jaeger

Basic Information

• Brand Name: Jaeger
• Primary DI: 04250892907345
• Version / Model: 3.30
• Catalog Number: V-770968
• Company Name: Jaeger Medical GmbH
• Labeler DUNS: 329769991
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-10-31
• Public Version: 2
• Public Version Date: 2025-11-20
• Public Version Status: Update
• Public Device Record Key: a6eba09c-7351-499b-aab1-a8ad7a150197

Device Description

SentrySuite Software

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BZC	Calculator, Pulmonary Function Data	Anesthesiology	868.1880	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47699	Cardiopulmonary physiological parameter analysis software, professional-only	A software program designed to add image processing and/or data analysis capabilities to a computer/workstation for the interpretation and/or screening of cardiopulmonary physiological parameters [e.g., electrocardiogram (ECG), blood pressure, vital capacity (VC)]; data may be uploaded, or collected in real-time by connection (e.g., wired, Bluetooth) to other devices for spot-checks and/or continuous monitoring. It is intended for use exclusively by healthcare professionals and may provide risk assessment for cardiopulmonary events [e.g., acute myocardial infarction (AMI)] or screen for specific conditions (e.g., low ejection fraction). It might include machine learning (ML) technology.	No	Active
66183	Pulmonary function analysis software, non-interpretive	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04250892907345	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K150810	000