Primary Device ID | 40841716100688 |
NIH Device Record Key | 4c3c0c91-3192-457b-bdc6-fbbbd9225b95 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ACIST RXi® Console, Refurbished |
Version Model Number | 018084 |
Company DUNS | 926684994 |
Company Name | ACIST MEDICAL SYSTEMS, 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 | true |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 40841716100688 [Primary] |
OBI | Catheter, Pressure Monitoring, Cardiac |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-09-09 |
20841716100004 - ACIST Navvus® Catheter | 2024-06-12 Navvus Catheter, p/n 701481-002 |
10841716100014 - ACIST Navvus® Catheter | 2024-06-12 Navvus Catheter, p/n 701481-003 |
30841716100384 - ACIST RXi® System | 2024-06-12 RXi System Console, p/n 701309-008 |
30841716101732 - ACIST RXi® System | 2024-06-12 RXi System Console, p/n 701640-001 |
10841716102421 - AngioTouch® Kit | 2024-06-07 Model AT X65 |
10841716103251 - AngioTouch® Kit | 2024-06-07 Model AT X65L |
30841716102524 - A1000V Single Use Syringe Kit | 2024-06-05 A1000V Single Use Syringe Kit Kit Contents: 100mL contrast reservoir and tubing with contrast spike and clamp. |
30841716100070 - ACIST CVi® Cart | 2024-05-31 CVi Cart, p/n 701351-001 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ACIST RXI 86110834 4791283 Live/Registered |
ACIST Medical Systems, Inc. 2013-11-05 |