FDA UDI
In Commercial Distribution
🇺🇸 United States
Curaplex
DI: 00815277028059
·
Model: 8600-ATFMLOK
·
BOUND TREE MEDICAL, LLC
Product Codes
7
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Curaplex
- Primary DI
- 00815277028059
- Version / Model
- 8600-ATFMLOK
- 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
- 4
- Public Version Date
- 2021-11-23
- Public Version Status
- Update
- Public Device Record Key
- 995a2797-3a87-4542-8b9c-b952d9d8b248
Device Description
*Custom* ATF Medic Load Out Kit 2016
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 |
|---|---|---|---|---|
| BTM | Ventilator, emergency, manual (resuscitator) | Anesthesiology | 868.5915 | 2 |
| OQU | airway monitoring system | Anesthesiology | 868.5730 | 2 |
| OGK | Orotrachael intubation guide kit | Anesthesiology | 868.1400 | 2 |
| KGZ | ACCESSORIES, CATHETER | General, Plastic Surgery | 878.4200 | 1 |
| PEZ | Central venous catheter dressing change kit | General Hospital | 880.5200 | 2 |
| CBP | Valve, non-rebreathing | Anesthesiology | 868.5870 | 2 |
| FMF | Syringe, piston | General Hospital | 880.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38092 | Capillary blood collection kit, home-use | A collection of devices and materials available for use by a patient/layperson outside a clinical setting to collect and mail a capillary blood sample to a clinical laboratory for diagnostic testing or screening purposes. The kit includes a lancet, a blood collection strip, dry blood collection card/filter paper card, and other items (e.g., alcohol prep pad, disposable lancet, gauze pad, bandage strip, and a container with a requisition form, for mailing to the laboratory). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815277028059 | GS1 |