Protecta-Gel®
- Primary DI
- 10850009091038
- Brand
- Protecta-Gel®
- Company
- J.R.J. MEDICAL INNOVATIONS, LLC
- Model
- JRJ 41501
- Catalog number
- JRJ 41501
- Device 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."
- 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 |
|---|---|
| FMP | Protector, Skin Pressure |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| FMP | Protector, Skin Pressure | General Hospital | 1 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 30850009091032 | Package | GS1 | 10 | In Commercial Distribution |
| 10850009091038 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 30850009091032 | 30850009091032 |
| 10850009091038 | 10850009091038 |
GMDN Terms#
| Term | Definition |
|---|---|
| Skin surface device adhesive | A 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 |
|---|---|---|
| Height | 3.5 | Millimeter |
| Length | 4.75 | Inch |
| Width | 4 | Inch |
Contacts#
| Phone | |
|---|---|
| 9999999999 | contact@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 | Catalog | Published |
|---|---|---|---|---|
| 10850009091052 | Stoma-Gel™ | JRJ 42501 | JRJ 42501 | 2022-01-10 |
| 10850009091045 | Protecta-Gel® | JRJ 41501SM | JRJ 41501SM | 2022-01-10 |
| 30850009091032 | Protecta-Gel® | JRJ 41501 | JRJ 41501 | 2022-01-10 |
| 30850009091049 | Protecta-Gel® | JRJ 41501SM | JRJ 41501SM | 2022-01-10 |
| 30850009091056 | Stoma-Gel™ | JRJ 42501 | JRJ 42501 | 2022-01-10 |
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