FDA UDI
In Commercial Distribution
🇺🇸 United States
First Responder Industrial Welding Burn Kit 5/Case
DI: M689IWKHA00020
·
Model: 02
·
Safeguard US Operating, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- First Responder Industrial Welding Burn Kit 5/Case
- Primary DI
- M689IWKHA00020
- Version / Model
- 02
- Catalog Number
- IWK-HA.00
- Company Name
- Safeguard US Operating, LLC
- Labeler DUNS
- 118492643
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-30
- Public Version
- 1
- Public Version Date
- 2025-08-07
- Public Version Status
- New
- Public Device Record Key
- 42efd651-da69-45c8-9607-e42f4a9b746e
Device Description
This kit offers a versatile combination of Burn Dressings, Burn Wrap/Fire Blankets and Burn Jel to meet emergency burn care needs in all resource limited settings (RLS) to better meet the different work environments of emergency medical and rescue first responders. It is designed and intended for use by emergency medical, rescue and non-medical personnel.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OJJ | Burn Kit Without Drug | General, Plastic Surgery | 878.4022 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10516 | Burn kit, non-medicated | A collection of devices designed to treat first or second degree burns typically as first aid therapy by emergency medical services (EMS); it does not include pharmaceuticals. It typically includes burn dressings, burn gels, gauze, cold packs, adhesive tapes, and gloves; it may include additional devices such as scissors and masks. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M689IWKHA00020 | HIBCC |