FDA UDI
In Commercial Distribution
🇺🇸 United States
BurnFree
DI: 00743537000357
·
Model: BSD400.02.000
·
WATER-JEL TECHNOLOGIES, L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
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Basic Information
- Brand Name
- BurnFree
- Primary DI
- 00743537000357
- Version / Model
- BSD400.02.000
- Catalog Number
- BSD400.02.000
- Company Name
- WATER-JEL TECHNOLOGIES, L.L.C.
- Labeler DUNS
- 155522589
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2024-10-25
- Public Version
- 1
- Public Version Date
- 2024-11-04
- Public Version Status
- New
- Public Device Record Key
- 1eb6ffdf-43b1-4369-9e63-140fff1193b8
Device Description
NEW Burn Stop 8"x8" dressing 50/case (REF BSD400R); BD Gel
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NAE | Dressing, Wound, Hydrogel Without Drug And/Or Biologic | General, Plastic Surgery | 878.4022 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47693 | Synthetic polymer burn dressing, gel-coated | A sterile covering designed to treat small to large patient burns. It is made from synthetic polymer material impregnated with wound gel (e.g., hydrogel) and is applied over the burn to protect against infection, minimize trauma and skin damage, moisten and cool the burn area, and prevent burn progression. It is available in various sizes (e.g., 10x10 cm to 60x40 cm) and may be body contoured; it is also available in prefabricated shapes (e.g., face mask). It is typically used by emergency medical services (EMS) and critical care units, but may also be used in the home. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00743537000623 | GS1 | ||||
| Primary | 00743537000357 | GS1 |
Customer Contacts
- Phone
- 855-428-6074
- [email protected]