FDA UDI
In Commercial Distribution
🇺🇸 United States
Curaplex
DI: 00810094577179
·
Model: 10-670034-KIT
·
BOUND TREE MEDICAL, LLC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Curaplex
- Primary DI
- 00810094577179
- Version / Model
- 10-670034-KIT
- Catalog Number
- 10-670034-KIT
- Company Name
- BOUND TREE MEDICAL, LLC
- Labeler DUNS
- 070556204
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-30
- Public Version
- 1
- Public Version Date
- 2024-08-07
- Public Version Status
- New
- Public Device Record Key
- 1ac08ffe-aeb9-4242-84f3-5cdb7013e6b6
Device Description
*CUSTOM* New Orleans OD Kit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CCQ | NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER) | Anesthesiology | 868.5640 | 1 |
| OHO | First aid kit without drug | General, Plastic Surgery | 878.4014 | 1 |
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 | 00810094577179 | GS1 |