SentrySuite Software V-770965

GUDID 04250892907352

SentrySuite Software

Jaeger Medical GmbH

Pulmonary function analysis software, non-interpretive

• Primary Device ID: 04250892907352
• NIH Device Record Key: a40df732-1ae6-4cea-8f49-d9412d351b27
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SentrySuite Software
• Version Model Number: 3.20
• Catalog Number: V-770965
• Company DUNS: 329769991
• Company Name: Jaeger Medical GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +499314972127
• Email: techsupport.int@jaegerrdx.com
• Phone: +499314972127
• Email: techsupport.int@jaegerrdx.com
• Phone: +499314972127
• Email: techsupport.int@jaegerrdx.com
• Phone: +499314972127
• Email: techsupport.int@jaegerrdx.com
• Phone: +499314972127
• Email: techsupport.int@jaegerrdx.com
• Phone: +499314972127
• Email: techsupport.int@jaegerrdx.com
• Phone: +499314972127
• Email: techsupport.int@jaegerrdx.com
• Phone: +499314972127
• Email: techsupport.int@jaegerrdx.com
• Phone: +499314972127
• Email: techsupport.int@jaegerrdx.com
• Phone: +499314972127
• Email: techsupport.int@jaegerrdx.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250892907352 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150810

FDA Product Code

• BZC: Calculator, Pulmonary Function Data

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-02
• Device Publish Date: 2025-11-24

Devices Manufactured by Jaeger Medical GmbH

• 04250892907352 - SentrySuite Software: 2025-12-02SentrySuite Software
• 04250892907352 - SentrySuite Software: 2025-12-02 SentrySuite Software
• 04250892908700 - Jaeger: 2025-12-02 APS Pro SA
• 04250892908717 - Jaeger: 2025-12-02 APS Pro SA
• 04250892908731 - Jaeger: 2025-12-02 MasterScreen IOS
• 04250892908816 - Jaeger: 2025-12-02 Replacement Handle for V-171470 MasterScreen Pneumo
• 04250892908823 - Jaeger: 2025-12-02 MasterScreen Pneumo
• 04250892908861 - Jaeger: 2025-12-02 MasterScreen Pneumo
• 04250892908984 - Jaeger: 2025-12-02 SentrySuite Server Software