SentrySuite V-770846

GUDID 04250892901053

SentrySuite Software

Vyaire Medical GmbH

Pulmonary function analysis system, adult

• Primary Device ID: 04250892901053
• NIH Device Record Key: f78dffe0-aac0-4922-85d5-bacb5ea6b86b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SentrySuite
• Version Model Number: 2.21
• Catalog Number: V-770846
• Company DUNS: 329769991
• Company Name: Vyaire 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: support.rt.eu.jae@carefusion.c
• Phone: +499314972127
• Email: support.rt.eu.jae@carefusion.com
• Phone: +499314972127
• Email: support.rt.eu.jae@carefusion.com
• Phone: +499314972127
• Email: support.rt.eu.jae@carefusion.com
• Phone: +499314972127
• Email: support.rt.eu.jae@carefusion.com
• Phone: +499314972127
• Email: support.rt.eu.jae@carefusion.com
• Phone: +499314972127
• Email: support.rt.eu.jae@carefusion.com
• Phone: +499314972127
• Email: support.rt.eu.jae@carefusion.com
• Phone: +499314972127
• Email: support.rt.eu.jae@carefusion.com
• Phone: +499314972127
• Email: support.rt.eu.jae@carefusion.com
• Phone: +499314972127
• Email: support.rt.eu.jae@carefusion.com
• Phone: +499314972127
• Email: support.rt.eu.jae@carefusion.com
• Phone: +499314972127
• Email: support.rt.eu.jae@carefusion.com
• Phone: +499314972127
• Email: support.rt.eu.jae@carefusion.com
• Phone: +499314972127
• Email: support.rt.eu.jae@carefusion.com
• Phone: +499314972127
• Email: support.rt.eu.jae@carefusion.com
• Phone: +499314972127
• Email: support.rt.eu.jae@carefusion.com
• Phone: +499314972127
• Email: support.rt.eu.jae@carefusion.com
• Phone: +499314972127
• Email: support.rt.eu.jae@carefusion.com
• Phone: +499314972127
• Email: support.rt.eu.jae@carefusion.com
• Phone: +499314972127
• Email: support.rt.eu.jae@carefusion.com
• Phone: +499314972127
• Email: support.rt.eu.jae@carefusion.com
• Phone: +499314972127
• Email: support.rt.eu.jae@carefusion.com
• Phone: +499314972127
• Email: support.rt.eu.jae@carefusion.com
• Phone: +499314972127
• Email: support.rt.eu.jae@carefusion.com
• Phone: +499314972127
• Email: support.rt.eu.jae@carefusion.com
• Phone: +499314972127
• Email: support.rt.eu.jae@carefusion.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250892901053 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-18
• Device Publish Date: 2017-11-17

Devices Manufactured by Vyaire Medical GmbH

• 14250892906833 - Vyaire: 2025-01-15 Extra Small Nasal Probes
• 14250892906840 - Vyaire: 2025-01-15 Small Nasal Probes
• 14250892906857 - Vyaire: 2025-01-15 Medium Nasal Probes
• 14250892906864 - Vyaire: 2025-01-15 Large Nasal Probes
• 04250892905945 - Vyaire: 2024-04-02 SentrySuite Software
• 04250892905211 - MasterScreen: 2022-03-03 MasterScreen Body/Diff
• 04250892905228 - MasterScreen: 2022-03-03 MasterScreen Body
• 14250892906543 - Vyaire: 2021-11-24 Mouthpiece Adaptor