VeyO2 Mask

Basic Information

• Brand Name: VeyO2 Mask
• Primary DI: 00858545007042
• Version / Model: 24002
• Company Name: DYNASTHETICS, LLC
• Labeler DUNS: 042681859
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-24
• Public Version: 1
• Public Version Date: 2024-10-02
• Public Version Status: New
• Public Device Record Key: afd086bc-1e1f-4984-b359-dd15cd3fb4f0

Device Description

Oxygen Mask

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CBN	Apparatus, Gas-Scavenging	Anesthesiology	868.5430	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36096	Halogenated vapour absorber	A refillable container (e.g., a canister) placed in an anaesthesia unit/workstation breathing circuit for the removal of halogenated vapours. This device is filled with an appropriate absorbent (e.g., activated charcoal) to chemically remove the halogenated vapours. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10858545007049	GS1		25	In Commercial Distribution
Primary	00858545007042	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K092031	000