SentrySuite V-770846

GUDID 04250892901053

SentrySuite Software

Vyaire Medical GmbH

Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult 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

• 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
• 14250892906550 - Vyaire: 2021-11-24 Turbine Complete
• 04250892906645 - Vyaire: 2021-11-23 Calibration Syringe 100 ml
• 14250892906499 - Vyaire: 2021-11-23 LED holder High/Low FIO2
• 14250892906529 - Vyaire: 2021-11-23 LED holder