Vitus 522

GUDID 10850025153048

Vitus 4" Seal

HR PHARMACEUTICALS INC.

Stomal appliance skin-adherent patch, non-sterile

• Primary Device ID: 10850025153048
• NIH Device Record Key: 6496c74b-7cad-400c-afb8-9cd70cbb2a6b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vitus
• Version Model Number: 522
• Catalog Number: 522
• Company DUNS: 828918164
• Company Name: HR PHARMACEUTICALS INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850025153041 [Primary]
GS1	10850025153048 [Package]; Contains: 00850025153041; Package: Box [10 Units]; In Commercial Distribution
GS1	50850025153046 [Package]; Package: Case [200 Units]; In Commercial Distribution

FDA Product Code

• EZS: APPLIANCE, COLOSTOMY, DISPOSABLE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-27
• Device Publish Date: 2021-05-19

On-Brand Devices [Vitus]

• 10850025153109: Vitus 2oz Paste No Sting
• 10850025153093: Vitus 2oz Paste
• 10850025153048: Vitus 4" Seal
• 50850025153039: Vitus 2" Seal Standard
• 50850025153022: Vitus 2" Seal Thin
• 50850025153015: Vitus Adhesive Remover Wipe
• 10850025153000: Vitus Skin Prep Wipe
• 50850025153084: Vitus 1/3 Crescent Barrier Ext
• 50850025153077: Vitus Lubricating Deodorant Spray Bottle
• 50850025153060: Vitus Lubricating Deodorant Packet
• 10850025153055: Vitus Lubricating Deodorant Disc Cap Bottle