Primary Device ID | 30841716101596 |
NIH Device Record Key | 94e96a1e-fedf-4851-b414-3cb23e411ec5 |
Commercial Distribution Discontinuation | 2020-01-14 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | ACIST HDi® Patient Interface Module (PIM) |
Version Model Number | 017989 |
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 | 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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10841716101592 [Primary] |
GS1 | 30841716101596 [Package] Contains: 10841716101592 Package: Shelf box [1 Units] Discontinued: 2020-01-14 Not in Commercial Distribution |
OBJ | Catheter, Ultrasound, Intravascular |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2024-05-09 |
Device Publish Date | 2016-11-11 |
10841716100632 - ACIST CVi® Angiographic Injection System Power Supply | 2024-05-17 CVi Power Supply p/n 701340-002 |
10841716101196 - ACIST CVi® Angiographic Injection System Control Panel | 2024-05-17 CVi Angiographic Injection System Control Panel, p/n 701557-001 |
10841716101233 - ACIST CVi® Angiographic Injection System Injector Head | 2024-05-17 CVi Injector, p/n 700706-009 |
10841716101349 - ACIST CVi® Angiographic Injection System Injector Head | 2024-05-17 CVi Injector (Siemens), p/n 700708-009 |
30841716102548 - A2000 Multi-use Syringe Kit | 2024-05-17 A2000 Multi-use Syringe Kit, p/n 701669-008 Kit Contents: 100mL contrast reservoir and tubing with contrast spike and clamp with |
30841716100254 - ACIST HDi® System Console | 2024-05-09 HDi System Console, p/n 701460-004 |
30841716100698 - ACIST HDi® Linear Translation System (LTS) | 2024-05-09 HDi LTS, p/n 701457-004 |
30841716101176 - ACIST HDi® Power Supply | 2024-05-09 HDi Power Supply, p/n 701560-002 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ACIST HDI 86110839 4898988 Live/Registered |
ACIST Medical Systems, Inc. 2013-11-05 |