FDA UDI
In Commercial Distribution
🇺🇸 United States
Curaplex®
DI: 00810094579326
·
Model: 8600-01551
·
BOUND TREE MEDICAL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Curaplex®
- Primary DI
- 00810094579326
- Version / Model
- 8600-01551
- Catalog Number
- 8600-01551
- Company Name
- BOUND TREE MEDICAL, LLC
- Labeler DUNS
- 070556204
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-06
- Public Version
- 1
- Public Version Date
- 2025-08-14
- Public Version Status
- New
- Public Device Record Key
- 3d6aeb5e-4183-4db7-bd0c-8109b6f59115
Device Description
*Custom* CPAP Conversion Kit XS
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- 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 |
|---|---|---|---|---|
| BZD | Ventilator, non-continuous (respirator) | Anesthesiology | 868.5905 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57813 | CPAP/BPAP face mask, single-use | A non-sterile, flexible, form-shaped device designed to be placed over a user's nose and mouth to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic/silicone materials that create an airtight seal around the nose and mouth. It is available in various designs and sizes and stabilized with a headstrap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00810094579449 | GS1 | CS | 10 | In Commercial Distribution | |
| Primary | 00810094579326 | GS1 |