VELA

Basic Information

• Brand Name: VELA
• Primary DI: 10190752153837
• Version / Model: 12194
• Catalog Number: 12194
• Company Name: VYAIRE MEDICAL, INC.
• Labeler DUNS: 080456871
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-29
• Public Version: 1
• Public Version Date: 2021-04-06
• Public Version Status: New
• Public Device Record Key: c3921b8a-1392-4396-970d-5f1944e357af

Device Description

KIT,OXIMETER MOUNT-VELA

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CBK	Ventilator, continuous, facility use	Anesthesiology	868.5895	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42514	Ventilator stand	A mobile device onto which a ventilator (not included) is designed to be mounted/secured so that the ventilator can be safely moved about. It is designed as a floor stand (a vertical pole with a horizontal platform or spars or other form of fastening mechanism) with a set of effectively-spaced wheels to provide mobility and stability.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10190752153837	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K093094	000