VeyO2 Mask

GUDID 10858545007049

Oxygen Mask

DYNASTHETICS, LLC

Halogenated vapour absorber

• Primary Device ID: 10858545007049
• NIH Device Record Key: afd086bc-1e1f-4984-b359-dd15cd3fb4f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VeyO2 Mask
• Version Model Number: 24002
• Company DUNS: 042681859
• Company Name: DYNASTHETICS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 801-484-3820
• Email: cservice@dynasthetics.com
• Phone: 801-484-3820
• Email: cservice@dynasthetics.com
• Phone: 801-484-3820
• Email: cservice@dynasthetics.com
• Phone: 801-484-3820
• Email: cservice@dynasthetics.com
• Phone: 801-484-3820
• Email: cservice@dynasthetics.com
• Phone: 801-484-3820
• Email: cservice@dynasthetics.com
• Phone: 801-484-3820
• Email: cservice@dynasthetics.com
• Phone: 801-484-3820
• Email: cservice@dynasthetics.com
• Phone: 801-484-3820
• Email: cservice@dynasthetics.com
• Phone: 801-484-3820
• Email: cservice@dynasthetics.com
• Phone: 801-484-3820
• Email: cservice@dynasthetics.com
• Phone: 801-484-3820
• Email: cservice@dynasthetics.com
• Phone: 801-484-3820
• Email: cservice@dynasthetics.com
• Phone: 801-484-3820
• Email: cservice@dynasthetics.com
• Phone: 801-484-3820
• Email: cservice@dynasthetics.com
• Phone: 801-484-3820
• Email: cservice@dynasthetics.com
• Phone: 801-484-3820
• Email: cservice@dynasthetics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858545007042 [Primary]
GS1	10858545007049 [Package]; Contains: 00858545007042; Package: [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092031

FDA Product Code

• CBN: Apparatus, Gas-Scavenging

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: 2024-10-02
• Device Publish Date: 2024-09-24

Devices Manufactured by DYNASTHETICS, LLC

• 00858545007028 - Sovant: 2024-10-02
• 10858545007032 - SmartProngs Cannula: 2024-10-02 Nasal Oxygen Cannula
• 10858545007049 - VeyO2 Mask: 2024-10-02Oxygen Mask
• 10858545007049 - VeyO2 Mask: 2024-10-02 Oxygen Mask
• 80858545007000 - Vapor Clean: 2018-07-06 Vapor Clean Filter
• 80858545007017 - Vapor Clean: 2018-07-06 Vapor Clean Filter