Primary Device ID | B357AMI1000 |
NIH Device Record Key | 95d89ebe-cd45-4731-bd39-6897aab42aa8 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Ellipsys Power Controller |
Version Model Number | AMI1000 |
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 | 949-276-2483 |
dcampbell@avenumedical.com | |
Phone | 949-276-2483 |
dcampbell@avenumedical.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B357AMI1000 [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 | 2018-10-19 |
Device Publish Date | 2018-09-18 |
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 |