Definition: The Heparin Flush In 0.45% Sodium Chloride Is Intended To Maintain Patency Of An Indwelling Intravenous Catheter Device Designed For Intermittent Injection Or Infusion Therapy Or Blood Sampling. It Provides An Alternative To Clinicians To Prevent Sod
| Device Type ID | 2739 |
| Device Name | Heparin Flush In 0.45% Sodium Chloride |
| Physical State | Transparent Container, Volume Markings On The Syringe Barrel, Tip Cap, Plunger Stopper And Heparin Lock Flush Solution |
| Technical Method | Attaach Syringe To Access Device And Flush. |
| Target Area | Heparin Lock Device Or Central Venous Catheter. |
| Regulation Description | Intravascular Catheter. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Infection Control Devices Branch (INCB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 880.5200 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PEF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 2739 |
| Device | Heparin Flush In 0.45% Sodium Chloride |
| Product Code | PEF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Intravascular Catheter. |
| CFR Regulation Number | 880.5200 [🔎] |