FDA UDI
In Commercial Distribution
🇺🇸 United States
Legend Aerospace
DI: 00850057805024
·
Model: LAI-5532A1-101
·
Legend Aerospace, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Legend Aerospace
- Primary DI
- 00850057805024
- Version / Model
- LAI-5532A1-101
- Catalog Number
- Legend Aerospace Enhanced Emergency Medical Kit 101 LAI-5532A1-101
- Company Name
- Legend Aerospace, Inc.
- Labeler DUNS
- 076906556
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-09
- Public Version
- 1
- Public Version Date
- 2024-02-19
- Public Version Status
- New
- Public Device Record Key
- 37115729-3711-418e-b555-aa2641899905
Device Description
Enhanced Emergency Medical Kit 101 LAI-5532A1-101
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| OKI | Emergency Response Safety Kit | General, Plastic Surgery | 878.4040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44039 | First aid kit, medicated | A convenient collection of equipment, materials and pharmaceuticals intended to be used in an emergency for the rapid, initial treatment of an injury. It is typically used by emergency medical services (EMS), hospitals, institutions, schools, and other public settings. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850057805024 | GS1 |