| Primary Device ID | B357AMI1001 |
| NIH Device Record Key | cc6d2f61-7670-4a26-9fa2-126ce1c3b003 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ellipsys Power Controller |
| Version Model Number | AMI1001 |
| Company DUNS | 053562774 |
| Company Name | AVENU MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(949)-276-2483 |
| customerservice@avenumedical.c | |
| Phone | +1(949)-276-2483 |
| customerservice@avenumedical.c |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B357AMI1001 [Primary] |
| PQK | Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-11-26 |
| Device Publish Date | 2018-10-24 |
| B357AMI1001 | The Ellipsys® Power Controller is the reusable control unit for the Ellipsys® Vascular Access |
| B357AMI1000 | AMI1000 |
| 00763000478193 | The Ellipsys® Power Controller is the reusable control unit for the Ellipsys® Vascular Access |
| 00763000574710 | The Ellipsys® Power Controller is the reusable control unit for the Ellipsys® Vascular Access |