Protecta-Gel®

Primary DI
30850009091049
Brand
Protecta-Gel®
Company
J.R.J. MEDICAL INNOVATIONS, LLC
Model
JRJ 41501SM
Catalog number
JRJ 41501SM
Device description
Protecta-Gel® Facial Skin Barrier, Small. Hypoallergenic and made from medical grade mineral oil-based gel. Super soft barrier between the patient's skin and their full face mask or nasal mask. Unique patented "pressure absorbing ribs" to help increase comfort and decrease soreness, marks and wounds to the nasal bridge, upper and lower cheek bone areas. Unlike other “gels or dressings currently on the market, the Protecta-Gel® is patented with a unique “Rib” like design solely responsible for added protection. This unique design replicates shock absorbers which create comfort for Non Invasive ventilation (NIV), CPAP full face mask users. The Protecta-Gel® allows the caregiver or user to “cut” or “trim” the product to size to ensure a more accurate fit. Tapered ends will help to prevent leaks and improve comfort. No adhesives necessary. Easy to clean with mild soap and water. Air dry. Replace after 30 days of use.
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
30850009091049PackageGS110In Commercial Distribution
10850009091045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3085000909104930850009091049
1085000909104510850009091045

GMDN Terms#

Term, Definition table
TermDefinition
Skin surface device adhesive, non-sterileA non-sterile substance (e.g., gel, aerosol) intended to adhere a medical device (e.g., dressing, ostomy device, aesthetic restoration prosthesis) to the skin surface; it is not intended for invasive/surgical use but may be intended for other non-patient contact uses. It may be used in the home or healthcare facility. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height3.5Millimeter
Length4Inch
Width3.75Inch

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
30850009091056Stoma-Gel™JRJ 42501JRJ 425012022-01-10

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