FDA.reportPublic FDA data

Stoma-Gel™

Primary DI
10850009091052
Brand
Stoma-Gel™
Company
J.R.J. MEDICAL INNOVATIONS, LLC
Model
JRJ 42501
Catalog number
JRJ 42501
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.
Published
2022-01-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMPProtector, Skin Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMPProtector, Skin PressureGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30850009091056PackageGS150In Commercial Distribution
10850009091052PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3085000909105630850009091056
1085000909105210850009091052

GMDN Terms#

Term, Definition table
TermDefinition
Removable ambulatory appliance skin-adherent patchA 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, implantable pulse generator (IPG) battery charger] 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height3Millimeter
Length73Millimeter
Width47Millimeter

Contacts#

Phone, Email table
PhoneEmail
9999999999contact@jrjmedical.com

Regulatory Flags#

DUNS number
015629325
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850009091038Protecta-Gel®JRJ 41501JRJ 415012022-01-10
10850009091045Protecta-Gel®JRJ 41501SMJRJ 41501SM2022-01-10
30850009091032Protecta-Gel®JRJ 41501JRJ 415012022-01-10
30850009091049Protecta-Gel®JRJ 41501SMJRJ 41501SM2022-01-10
30850009091056Stoma-Gel™JRJ 42501JRJ 425012022-01-10

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