VIVIT Supply

Basic Information

• Brand Name: VIVIT Supply
• Primary DI: 10810141931050
• Version / Model: 12EL
• Company Name: Vivit Supply LLC
• Labeler DUNS: 119042597
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2023-09-15
• Public Version: 1
• Public Version Date: 2023-09-25
• Public Version Status: New
• Public Device Record Key: cc26163f-9d65-4ba4-bb43-8b30d3f0c3a1

Device Description

Eyewear, Lens, Anti-Glare / Anti-Fog, Multicolored

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• 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
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	886.4750	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58376	Eye splash shield, single-use	A device intended to be worn over the eyes to protect (shield) the healthcare worker from blood and other body fluid splashes while performing a clinical or laboratory procedure. It may have an open design like spectacles, or an enclosed design like goggles or a mask. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20810141931057	GS1	Case	5	In Commercial Distribution
Primary	10810141931050	GS1
Unit of Use	00810141931053	GS1

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in cool, dry, and well ventilated space out of direct sunlight