Stoma-Gel™

Basic Information

• Brand Name: Stoma-Gel™
• Primary DI: 10850009091052
• Version / Model: JRJ 42501
• Catalog Number: JRJ 42501
• Company Name: J.R.J. MEDICAL INNOVATIONS, LLC
• Labeler DUNS: 015629325
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-01-10
• Public Version: 3
• Public Version Date: 2023-11-03
• Public Version Status: Update
• Public Device Record Key: 93b81420-19ee-4221-beca-007130751611

Device Description

Stoma-Gel™ pads are hypoallergenic and made from a medical grade, mineral oil-based gel. Stoma-Gel™ pads are a super soft barrier between the tracheostomy tube flange and sterile gauze. The pads unique cushioning material to help increase comfort and decrease soreness, marks, and wounds around the tracheostomy stoma area. One size fits most - slight cut can be made to fit size 9 tracheostomy tubes or larger. No adhesives necessary. Easy to clean with mild soap and water. Air dry.

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
FMP	Protector, Skin Pressure	General Hospital	880.6450	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	30850009091056	GS1	Box	50	In Commercial Distribution
Primary	10850009091052	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	73	Millimeter
Width	47	Millimeter
Height	3	Millimeter