Console

Basic Information

• Brand Name: Console
• Primary DI: 07290016746716
• Version / Model: MM40000-US
• Catalog Number: MM40000-US
• Company Name: VIORA LTD
• Labeler DUNS: 514612758
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-22
• Public Version: 3
• Public Version Date: 2025-09-09
• Public Version Status: Update
• Public Device Record Key: 8e244202-3b4f-4fc2-8f32-2346d3b5f0f0

Device Description

EnerJet Console

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• 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
KZE	Injector, Fluid, Non-Electrically Powered	General Hospital	880.5430	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42949	Needleless medication/vaccine injector, pneumatic	A hand-held, pneumatically-powered device designed to inject medication (especially a local anaesthetic) or vaccine transcutaneously into the human body. It is needleless and may have various configurations according to its application. It will typically be a pistol-shaped plunger driven instrument with single or multi-pointed holed barrels through which the medication/vaccine is driven under high pressure by compressed gas. The delivered medication/vaccine will typically be supplied in prefilled containers that are loaded into the device. This is not a hypodermic syringe. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290016746716	GS1

Customer Contacts

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