FDA UDI
In Commercial Distribution
🇺🇸 United States
Individual Personal Protective Equipment
DI: M68981411020
·
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
- Individual Personal Protective Equipment
- Primary DI
- M68981411020
- Version / Model
- 02
- Catalog Number
- 81-411
- Company Name
- Safeguard US Operating, LLC
- Labeler DUNS
- 118492643
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-25
- Public Version
- 1
- Public Version Date
- 2026-03-05
- Public Version Status
- New
- Public Device Record Key
- 4166b3c0-5c81-420b-8200-9057d2e28ce7
Device Description
Apart of the Treatment Support Kits of Convenience Family of Products that's designed and intended for use by non-medical personnel. The Individual Personal Protective Equipment (PPE) Set provides the user with Level 3 biohazard protection for boarding/recovery operations, mass casualty incidents or when otherwise needed.
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 |
|---|---|---|---|---|
| OKG | Body Fluid Clean Up Kit | General, Plastic Surgery | 878.4040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44047 | First aid kit, non-medicated, single-use | A convenient collection of equipment and materials intended to be used in an emergency for the rapid, initial treatment of an injury. This device is typically used by emergency medical services (EMS), institutions, schools, the home, motor vehicles, and other public settings. This device does not contain medicinal substances/pharmaceuticals. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M68981411020 | HIBCC |
Customer Contacts
- Phone
- 855-428-6074
- [email protected]