FDA UDI Not in Commercial Distribution 🇺🇸 United States

ACIST CVi® Angiographic Injection System

DI: 40841716100602 · Model: 014657 · ACIST MEDICAL SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
ACIST CVi® Angiographic Injection System
Primary DI
40841716100602
Version / Model
014657
Company Name
ACIST MEDICAL SYSTEMS, INC.
Labeler DUNS
926684994
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-09
Public Version
3
Public Version Date
2019-04-15
Public Version Status
Update
Public Device Record Key
fc581410-a162-452e-836c-120f7ca76747
Distribution End Date
2018-12-19

Device Description

CVi Injector p/n 800620-019 Contents: CVi Injector Head, Bed Mount, & Power Supply

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
DXT Injector And Syringe, Angiographic

GMDN Terms

Code Name
57997 Angiography contrast medium injection system, line-powered, mobile

Identifiers

Type ID
Primary 40841716100602