Definition: Disinfect Needleless Access Valves And May Act As A Physical Barrier To Contamination If Not Removed For A Set Period Of Time
| Device Type ID | 2866 |
| Device Name | Cap, Device Disinfectant |
| Physical State | A Molded Cap With A Disinfectant Pad To Fit On A Luer Access Device |
| Technical Method | Fits On A Luer Access Valve To Disinfect The Valve, Then Act As Physical Barrier To Contamination |
| Target Area | Intravascular |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(k) |
| FDA Device Classification | Class Unclassified Medical Device |
| Product Code | QBP |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2866 |
| Device | Cap, Device Disinfectant |
| Product Code | QBP |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CATHETER CONNECTIONS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
IVERA MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |