Product code NZW
- Device name
- Heparin, Vascular Access Flush
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.5200
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K163591 | BD PosiFlush Heparin Lock Flush Syringe | Becton, Dickinson and Company | 2017-02-27 |
| K133446 | HEPARIN LOCK / FLUSH SYRINGES | Excelsior Medical Corporation | 2014-11-14 |
| K092938 | HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710 | App Pharmaceuticals, LLC | 2010-06-18 |
| K092491 | MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN VARIOUS FILL SIZES | Medefil, Inc. | 2010-02-03 |
| K090680 | HEPARIN LOCK FLUSH SOLUTION, USP BD POSIFLUSH HEPARIN LOCK FLUSH SYRINGE | Becton, Dickinson & CO | 2009-06-10 |
| K061497 | SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML | Excelsior Medical Corp. | 2007-02-23 |
| K023740 | SYREX PRE-FILLED SYRINGE | Excelsior Medical Corp. | 2003-05-13 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10888277675896 | PENDING | MEDLINE INDUSTRIES, INC. | 2020-06-01 |
| 10888277675902 | PENDING | MEDLINE INDUSTRIES, INC. | 2020-06-01 |
| 20612479247714 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2019-10-04 |
| 20612479247745 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2019-10-04 |
| 20612479247776 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2019-10-04 |
| 20612479247806 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2019-10-04 |
| 30364253444235 | Medefil Heparin Lock Flush Syringe, 1 Unit/mL | MEDEFIL, INC. | 2016-12-15 |
| 30364253444303 | Medefil Heparin Lock Flush Syringe, 1 Unit/mL | MEDEFIL, INC. | 2016-12-14 |
| 30364253444211 | Medefil Heparin Lock Flush Syringe, 1 Unit/mL | MEDEFIL, INC. | 2016-12-14 |
| 30364253333522 | Medefil Lock Flush Syringe, 1000 Unit/mL | MEDEFIL, INC. | 2016-12-14 |
| 30364253333300 | Medefil Heparin Lock Flush Syringe, 100 Unit/mL | MEDEFIL, INC. | 2016-12-14 |
| 30364253333256 | Heparin Lock Flush Syringe, 100 Unit/mL | MEDEFIL, INC. | 2016-12-14 |
| 30364253333225 | Heparin Lock Flush Syringe 100 Unit /mL | MEDEFIL, INC. | 2016-12-14 |
| 30364253222529 | Heparin Lock Flush Syringe, 10 Unit/mL | MEDEFIL, INC. | 2016-12-14 |
| 30364253222307 | Medefil Heparin Lock Flush Syringe, 10 Unit/mL | MEDEFIL, INC. | 2016-12-14 |
| 30364253222253 | Heparin Lock Flush Syringe, 10 Unit/mL | MEDEFIL, INC. | 2016-12-14 |
| 30364253222222 | Medefil Heparin Lock Flush Syringe, 10 Unit/mL | MEDEFIL, INC. | 2016-12-14 |
| 30364253444334 | Medefil Heparin Lock Flush Syringe, 1 Unit/mL | MEDEFIL, INC. | 2016-12-14 |
| 30364253444358 | Medefil Heparin Lock Flush Syringe, 1 Unit/mL | MEDEFIL, INC. | 2016-12-14 |
| 30364253444525 | Medefil Heparin Lock Flush Syringe, 1 Unit/mL | MEDEFIL, INC. | 2016-12-14 |
| 10363807500553 | Excelsior | MEDLINE INDUSTRIES, INC. | 2016-09-24 |
| 10363807600550 | Excelsior | MEDLINE INDUSTRIES, INC. | 2016-09-24 |
| 30363807600516 | Excelsior | MEDLINE INDUSTRIES, INC. | 2016-09-19 |
| 10363807600512 | Excelsior | MEDLINE INDUSTRIES, INC. | 2016-09-19 |
| 10363807500515 | Excelsior | MEDLINE INDUSTRIES, INC. | 2016-09-19 |
| 00363807500051 | Excelsior | MEDLINE INDUSTRIES, INC. | 2016-09-19 |
| 00363807600058 | Excelsior | MEDLINE INDUSTRIES, INC. | 2016-09-19 |
| 00382903064137 | BD PosiFlush | BECTON, DICKINSON AND COMPANY | 2016-09-16 |
| 00382903064144 | BD PosiFlush | BECTON, DICKINSON AND COMPANY | 2016-09-16 |
| 30364253222352 | Heparin Lock Flush Syringe 10 Units/mL | MEDEFIL, INC. | 2016-04-21 |