Identity
- Trade Name
- First Responder Industrial Welding Burn Kit 5/Case FDA UDI
- Generic Name
- Burn kit, non-medicated FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 02 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- IWK-HA.00 FDA UDI
- Primary DI / UDI-DI
- M689IWKHA00020 FDA UDI
- FDA Product Code
- OJJ FDA UDI
- GMDN Term
- Burn kit, non-medicated FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4022 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Burn kit, non-medicated
First Responder Industrial Welding Burn Kit 5/Case by Safeguard Us Operating, 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
- Safeguard Us Operating, Llc
Sources (1)
- FDA UDI 42efd651-da69-45c8-9607-e42f4a9b746e 34 fields · synced Jun 1, 2026