Definition: Enhance The Performance Of Intravascular Catheters, To Maintain Patency Of The Vascular Catheter When It Is Not In Use.
| Device Type ID | 2693 |
| Device Name | Saline, Vascular Access Flush |
| 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 | NGT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 2693 |
| Device | Saline, Vascular Access Flush |
| Product Code | NGT |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Intravascular Catheter. |
| CFR Regulation Number | 880.5200 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BD | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
BECTON DICKINSON AND COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BECTON, DICKINSON & CO. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BECTON, DICKINSON AND COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
EXCELSIOR MEDICAL CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EXCELSIOR MEDICAL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDLINE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDLINE INDUSTRIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MRP, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NURSE ASSIST, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Appropriate Term/Code Not Available | 24 |
Device Contaminated During Manufacture Or Shipping | 7 |
Material Fragmentation | 6 |
Packaging Problem | 6 |
Nonstandard Device | 5 |
Manufacturing, Packaging Or Shipping Problem | 5 |
Product Quality Problem | 4 |
Material Deformation | 3 |
Leak / Splash | 3 |
Device Contamination With Chemical Or Other Material | 2 |
Unsealed Device Packaging | 2 |
Device Packaging Compromised | 2 |
Device Operates Differently Than Expected | 2 |
Infusion Or Flow Problem | 1 |
Defective Component | 1 |
Material Discolored | 1 |
Degraded | 1 |
Syringe | 1 |
Break | 1 |
| Total Device Problems | 77 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Becton Dickinson & Company | II | Sep-22-2014 |
| 2 | Centurion Medical Products Corporation | II | Sep-19-2014 |
| 3 | Covidien LLC | II | Sep-01-2015 |
| 4 | MRP, LLC Dba AMUSA | II | Aug-27-2015 |
| 5 | MRP, LLC Dba AMUSA | II | Jun-15-2015 |
| 6 | MRP, LLC Dba AMUSA | II | Jun-04-2015 |
| 7 | Medline Industries Inc | II | Aug-29-2018 |
| 8 | Merit Medical Systems, Inc. | I | Feb-20-2014 |
| 9 | Nurse Assist, Inc | I | Jan-03-2017 |