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Protecta-Gel®

FDA UDI

Class I (US FDA UDI)

by J.r.j. Medical Innovations, Llc

Identity

Trade Name
Protecta-Gel® FDA UDI
Generic Name
Skin surface device adhesive FDA UDI
Device Name
Protecta-Gel® Facial Skin Barrier, Regular. 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. FDA UDI
Model / Reference
JRJ 41501 FDA UDI
Description
Protecta-Gel® Facial Skin Barrier, Regular. 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. FDA UDI

Identifiers

Catalog Number
JRJ 41501 FDA UDI
Primary DI / UDI-DI
10850009091038 FDA UDI
FDA Product Code
FMP FDA UDI
GMDN Term
Skin surface device adhesive FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.6450 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 4.75 Inch FDA UDI
Width — 4 Inch FDA UDI
Height — 3.5 Millimeter FDA UDI

Category: Skin surface device adhesive

Protecta-Gel® by J.r.j. Medical Innovations, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Skin surface device adhesive.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
J.r.j. Medical Innovations, Llc

Sources (1)

  • FDA UDI aee92b02-c845-4c0c-a801-f26c0083c506 36 fields · synced May 30, 2026