| Primary Device ID | 00863656000325 |
| NIH Device Record Key | 1c32e000-db71-407a-a57e-1595acc01418 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FLEX Vessel Prep System |
| Version Model Number | FSC 4-75 |
| Catalog Number | FSC 4-75 |
| Company DUNS | 027796091 |
| Company Name | VENTUREMED GROUP, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Catheter Length | 75 Centimeter |
| Catheter Length | 75 Centimeter |
| Catheter Length | 75 Centimeter |
| Catheter Length | 75 Centimeter |
| Catheter Length | 75 Centimeter |
| Catheter Length | 75 Centimeter |
| Catheter Length | 75 Centimeter |
| Catheter Length | 75 Centimeter |
| Catheter Length | 75 Centimeter |
| Catheter Length | 75 Centimeter |
| Catheter Length | 75 Centimeter |
| Catheter Length | 75 Centimeter |
| Catheter Length | 75 Centimeter |
| Catheter Length | 75 Centimeter |
| Catheter Length | 75 Centimeter |
| Catheter Length | 75 Centimeter |
| Catheter Length | 75 Centimeter |
| Catheter Length | 75 Centimeter |
| Catheter Length | 75 Centimeter |
| Catheter Length | 75 Centimeter |
| Catheter Length | 75 Centimeter |
| Catheter Length | 75 Centimeter |
| Catheter Length | 75 Centimeter |
| Catheter Length | 75 Centimeter |
| Catheter Length | 75 Centimeter |
| Catheter Length | 75 Centimeter |
| Catheter Length | 75 Centimeter |
| Catheter Length | 75 Centimeter |
| Catheter Length | 75 Centimeter |
| Catheter Length | 75 Centimeter |
| Catheter Length | 75 Centimeter |
| Catheter Length | 75 Centimeter |
| Catheter Length | 75 Centimeter |
| Catheter Length | 75 Centimeter |
| Catheter Length | 75 Centimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00863656000325 [Primary] |
| PNO | Catheter, Percutaneous, Cutting/Scoring |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-04-11 |
| Device Publish Date | 2023-04-03 |
| 00863656000325 - FLEX Vessel Prep System | 2023-04-11FLEX Vessel Prep System, FSC 4-75 |
| 00863656000325 - FLEX Vessel Prep System | 2023-04-11 FLEX Vessel Prep System, FSC 4-75 |
| 00863656000301 - FLEX | 2019-07-05 FLEX Vessel Prep System Long Basket |
| 00863656000318 - FLEX AV | 2019-07-05 FLEX Vessel Prep system for arteriovenous fistulae |