Vmax 28278-001

GUDID 10190752162013

CARDIOSOFT V6.73 CAM14 W/USB

VYAIRE MEDICAL, INC.

Pulmonary function analysis system, adult

• Primary Device ID: 10190752162013
• NIH Device Record Key: 265a7174-651f-484a-bbf8-db380d7f16ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vmax
• Version Model Number: 28278-001
• Catalog Number: 28278-001
• Company DUNS: 080456871
• Company Name: VYAIRE MEDICAL, INC.
• 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: true
• 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: +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	10190752162013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K942211

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-28
• Device Publish Date: 2021-07-20

On-Brand Devices [Vmax]

• 10190752166882: APS PRO SA / VMAX OPTION
• 10190752164765: SWR KIT JLAB SWR W/VMAX SERIES
• 10190752164567: AUTO IVC 4 L 220/240V
• 10190752164413: SHIP KIT VMAX-229 ENCORE
• 10190752164406: SHIP KIT VMAX-22 ENCORE
• 10190752164376: Vmax ENCORE 229C
• 10190752164260: Vmax ENCORE 22
• 10190752164253: VMAX ENCORE 229 W/O GAS REG
• 10190752164246: Vmax ENCORE 229
• 10190752164154: IOS VMAX SERIES OPTION-ICU CART
• 10190752163997: LC CART ASSY W/CBLS VMAX DOM
• 10190752163010: SWR KIT, DATA CONVERT - VMAX TO SQL
• 10190752160859: PHYSICIANS CHOICE ENCORE LAPTOP
• 10190752118140: SHIP KIT VMAX-20 ENCORE
• 10190752118089: SHIP KIT BASIC AUTOBX V62J
• 10190752117501: AUTO IVC ENCL 4 LITER
• 10190752117396: VMAX ENCORE 29C
• 10190752117372: VMAX ENCORE 29N
• 10190752117365: Vmax ENCORE 29
• 10190752117358: Vmax ENCORE 29
• 10190752168244: E5550 WIN 7-64 ENG 100-240V JLAB
• 10190752164826: E5570 WIN7-64 ENG 100-240V JLAB
• 10190752162013: CARDIOSOFT V6.73 CAM14 W/USB
• 10190752117822: GAS, 16% O2, 4% CO2, BAL. N2
• 10190752114289: E5570 WIN7-64 ENG 100-240V SES
• 10190752114036: SWR KIT CARDIOSOFT V6.73
• 10190752114029: SWR PKG CARDIOSOFT V6.73