LTV2 28769-001

GUDID 10190752144897

Bracket, Cord Wrap, LTV2 Rolling Stand

VYAIRE MEDICAL, INC.

Desk mount Desk mount Desk mount Desk mount Desk mount Desk mount Desk mount Desk mount Desk mount Desk mount Desk mount Desk mount Desk mount

• Primary Device ID: 10190752144897
• NIH Device Record Key: a058f98f-f56d-467d-82ea-049774514b11
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LTV2
• Version Model Number: 28769-001
• Catalog Number: 28769-001
• 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: true
• 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: +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	10190752144897 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101643

FDA Product Code

• CBK: Ventilator, continuous, facility use

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: 2021-03-09
• Device Publish Date: 2021-03-01

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• 10190752144897: Bracket, Cord Wrap, LTV2 Rolling Stand
• 10190752144880: Basket, LTV2 Rolling Stand
• 10190752144873: LTV/LTV2 Rolling Stand