Duns Number:015629325
Device Description: Protecta-Gel® Facial Skin Barrier, Small. Hypoallergenic and made from medical grade miner 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.
Catalog Number
JRJ 41501SM
Brand Name
Protecta-Gel®
Version/Model Number
JRJ 41501SM
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FMP
Product Code Name
Protector, Skin Pressure
Public Device Record Key
b113dffc-5b92-4caf-b156-a109be20fa5b
Public Version Date
January 18, 2022
Public Version Number
1
DI Record Publish Date
January 10, 2022
Package DI Number
30850009091049
Quantity per Package
10
Contains DI Package
10850009091045
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |