MasterScreen V-175428

GUDID 04250892905228

MasterScreen Body

Vyaire Medical GmbH

Whole-body plethysmograph Whole-body plethysmograph Whole-body plethysmograph Whole-body plethysmograph Whole-body plethysmograph Whole-body plethysmograph Whole-body plethysmograph Whole-body plethysmograph Whole-body plethysmograph Whole-body plethysmograph Whole-body plethysmograph Whole-body plethysmograph Whole-body plethysmograph Whole-body plethysmograph Whole-body plethysmograph Whole-body plethysmograph Whole-body plethysmograph

• Primary Device ID: 04250892905228
• NIH Device Record Key: 12f4eccb-626a-4f83-bbd5-9e882c7218cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MasterScreen
• Version Model Number: V-175428
• Catalog Number: V-175428
• 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: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250892905228 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122699

FDA Product Code

• BTY: CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-03-03
• Device Publish Date: 2021-04-09

On-Brand Devices [MasterScreen]

• 04250892905228: MasterScreen Body
• 04250892905211: MasterScreen Body/Diff