Primary Device ID | 10841716102148 |
NIH Device Record Key | 2805a6df-9719-46f0-b33d-1c70619757a0 |
Commercial Distribution Discontinuation | 2020-01-14 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | ACIST HDi® System Console |
Version Model Number | 017987 |
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 | 10841716102148 [Primary] |
OBJ | Catheter, Ultrasound, Intravascular |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2024-05-09 |
Device Publish Date | 2019-01-04 |
10841716102148 | HDi System Console, p/n 701460-006 |
10841716101851 | HDi System Console, p/n 701460-005 |
30841716100254 | HDi System Console, p/n 701460-004 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ACIST HDI 86110839 4898988 Live/Registered |
ACIST Medical Systems, Inc. 2013-11-05 |