Vortex

Basic Information

• Brand Name: Vortex
• Primary DI: 00744229440857
• Version / Model: 044F8100
• Company Name: PARI RESPIRATORY EQUIPMENT, INC.
• Labeler DUNS: 804736098
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-04-30
• Public Version: 1
• Public Version Date: 2024-05-08
• Public Version Status: New
• Public Device Record Key: 01f042a5-a287-44e2-a935-8bd1a233c5be

Device Description

Mask, VORTEX, Pediatric Small

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
BYG	Mask, Oxygen	Anesthesiology	868.5580	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62042	Nebulizing system delivery set, reusable	A collection of non-sterile devices intended to be connected to a nebulizer system gas compressor or medical gas outlet to create/deliver an aerosol, usually medicated, to the patients respiratory system. It typically includes flexible tubing with connectors, a mask or mouthpiece, and a nebulizing medication chamber; pharmaceuticals are not included. This is a single-patient, reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00744229100850	GS1	carton	50	In Commercial Distribution
Primary	00744229440857	GS1