FDA.reportPublic FDA data

Stoma-Gel™

Primary DI
30850009091056
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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
Stomal appliance skin-adherent patch, non-sterileA non-sterile patch with a pressure-sensitive adhesive coating designed to be adhered to the skin around a stoma (e.g., tracheostoma, urostoma) to permit attachment of a stomal device (e.g., tracheostomy base plate) to the patient. It is made of synthetic polymer materials (e.g., polyurethane) and some types have a central opening to fit the appliance. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height3Millimeter
Length73Millimeter
Width47Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9999999999contact@jrjmedical.com

Regulatory Flags#

DUNS number
015629325
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850009091052Stoma-Gel™JRJ 42501JRJ 425012022-01-10
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

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