MasterScreen PFT V-172521

GUDID 04250892901015

MasterScreen PFT

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

• Primary Device ID: 04250892901015
• NIH Device Record Key: f8482403-6580-4a86-8e20-069478f565b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MasterScreen PFT
• Version Model Number: V-172521
• Catalog Number: V-172521
• 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: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• 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

Operating and Storage Conditions

• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250892901015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122699

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: 2017-04-10

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• 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