FDA UDI
In Commercial Distribution
🇺🇸 United States
Curaplex
DI: 00815277022835
·
Model: NSSSTARTB
·
BOUND TREE MEDICAL, LLC
Product Codes
7
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Curaplex
- Primary DI
- 00815277022835
- Version / Model
- NSSSTARTB
- Company Name
- BOUND TREE MEDICAL, LLC
- Labeler DUNS
- 070556204
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-14
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 89b0ac26-b6af-4f84-bded-704aae2814d4
Device Description
USSS START KIT BASIC
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DXQ | blood pressure cuff | Cardiovascular | 870.1120 | 2 |
| DXN | SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | Cardiovascular | 870.1130 | 2 |
| OKH | Body fluids barrier kit | General, Plastic Surgery | 878.4040 | 2 |
| BTM | Ventilator, emergency, manual (resuscitator) | Anesthesiology | 868.5915 | 2 |
| CFW | COPPER REDUCTION, GLUCOSE | Clinical Chemistry | 862.1345 | 2 |
| CBP | Valve, non-rebreathing | Anesthesiology | 868.5870 | 2 |
| DQA | Oximeter | Cardiovascular | 870.2700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43000 | First aid kit, non-medicated, reusable | 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 reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815277022835 | GS1 |