Vitus

Basic Information

• Brand Name: Vitus
• Primary DI: 00850025153041
• Version / Model: 522
• Catalog Number: 522
• Company Name: HR PHARMACEUTICALS INC.
• Labeler DUNS: 828918164
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-19
• Public Version: 3
• Public Version Date: 2023-11-03
• Public Version Status: Update
• Public Device Record Key: 6496c74b-7cad-400c-afb8-9cd70cbb2a6b

Device Description

Vitus 4" Seal

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: 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
EZS	APPLIANCE, COLOSTOMY, DISPOSABLE	Gastroenterology, Urology	876.5900	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62175	Removable ambulatory appliance skin-adherent patch	A patch with a pressure-sensitive adhesive coating designed to be adhered to the skin to temporarily secure/affix a removable patient-worn ambulatory appliance (e.g., tracheostomy base plate, insulin infusion pump) to the body. It is made of synthetic polymer materials [e.g., polyurethane] and is available in various designs (e.g., round, slot, spiral, with a central opening to fit the wearable appliance). It is not intended to adhere an external aesthetic restoration prosthesis (e.g., artificial nose, breast prosthesis) to the skin surface. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850025153048	GS1	Box	10	In Commercial Distribution
Primary	00850025153041	GS1
Package	50850025153046	GS1	Case	200	In Commercial Distribution

Customer Contacts

• Phone: [phone] ext. 110
• Email: [email protected]