| Primary Device ID | B357AMI6050 |
| NIH Device Record Key | 80a183c1-2a8b-4223-a1ba-cc40c6706471 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ellipsys Vascular Access System |
| Version Model Number | AMI6050 |
| Company DUNS | 053562774 |
| Company Name | AVENU MEDICAL, 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 |
| Phone | 949-276-2483 |
| dcampbell@avenumedical.com | |
| Phone | 949-276-2483 |
| dcampbell@avenumedical.com |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B357AMI6050 [Primary] |
| PQK | Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-19 |
| Device Publish Date | 2018-09-18 |
| B357AMI6050 | The Ellipsys Vascular Access System is indicated for the creation of a proximal radial artery to |
| B357AMI6005 | The Ellipsys® Vascular Access System is indicated for the creation of a proximal radial artery |
| 00763000496982 | The Ellipsys® Vascular Access System is indicated for the creation of a proximal radial artery |
| 00763000496975 | The Ellipsys® Vascular Access System is indicated for the creation of a proximal radial artery |