Identity
- Trade Name
- Stoma-Gel™ FDA UDI
- Generic Name
- Removable ambulatory appliance skin-adherent patch FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- JRJ 42501 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- JRJ 42501 FDA UDI
- Primary DI / UDI-DI
- 10850009091052 FDA UDI
- FDA Product Code
- FMP FDA UDI
- GMDN Term
- Removable ambulatory appliance skin-adherent patch 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 — 73 Millimeter FDA UDIWidth — 47 Millimeter FDA UDIHeight — 3 Millimeter FDA UDI
Category: Removable ambulatory appliance skin-adherent patch
Stoma-Gel™ by J.r.j. Medical Innovations, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- J.r.j. Medical Innovations, Llc
Sources (1)
- FDA UDI 93b81420-19ee-4221-beca-007130751611 36 fields · synced May 30, 2026