FDA UDI Not in Commercial Distribution 🇺🇸 United States

A2000 Multi-use Syringe Kit

DI: 10841716100069 · Model: 014612 · ACIST MEDICAL SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
A2000 Multi-use Syringe Kit
Primary DI
10841716100069
Version / Model
014612
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
4
Public Version Date
2020-04-20
Public Version Status
Update
Public Device Record Key
e541e4b8-98cd-4dbd-923e-5ce0d2e17332
Distribution End Date
2018-05-21

Device Description

A2000 Multi-use Syringe Kit, p/n 700334-014 Kit Contents: 100mL contrast reservoir and tubing with contrast spike and clamp

Device Characteristics

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

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
DXT Injector And Syringe, Angiographic

GMDN Terms

Code Name
47259 Contrast medium injection system syringe

Identifiers

Type ID
Package 30841716100063
Primary 10841716100069