Vmax 28278-001

GUDID 10190752162013

CARDIOSOFT V6.73 CAM14 W/USB

VYAIRE MEDICAL, INC.

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: 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