FDA UDI
In Commercial Distribution
🇺🇸 United States
Curaplex
DI: 00815277021852
·
Model: 677555-1
·
BOUND TREE MEDICAL, LLC
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Curaplex
- Primary DI
- 00815277021852
- Version / Model
- 677555-1
- Catalog Number
- 677555-1
- 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
- 2022-08-16
- Public Version Status
- Update
- Public Device Record Key
- c517cea6-0bcd-491b-af65-2a6248ea9fd0
Device Description
CPAP/Capnography Kit, O2MAX Neb Bitrac ED Mask, Adult LG, 3-SET, Ohmeda Connect, CO2 Sampling Line
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
- Yes
- 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 |
|---|---|---|---|---|
| BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | Anesthesiology | 868.5905 | 2 |
| BYE | Attachment, breathing, positive end expiratory pressure | Anesthesiology | 868.5965 | 2 |
| CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE | Anesthesiology | 868.1400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61655 | In-line CPAP set, non-nebulizing | A portable collection of devices intended to be connected to a medical gas supply to assist non-intubated ventilation (i.e., without an artificial airway) using continuous positive airway pressure (CPAP) during spontaneous patient respiration in respiratory emergency situations and/or respiratory therapy settings. It includes an in-line/gas-line CPAP device (a small plastic unit intended to establish a gas pressure proportional to gas flow rate), a mouthpiece or face mask, and may include additional components (e.g., tubing, manometer gauge); it does not include a nebulizer. This is a single-patient, reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815277021852 | GS1 | ||||
| Package | 00810094571795 | GS1 | CS | 15 | In Commercial Distribution |