Multi-use Syringe Kit

GUDID 30841716101633

Model A2000V, p/n 701259-006 Kit Contents: 100mL contrast reservoir and tubing with contrast spike and clamp

ACIST MEDICAL SYSTEMS, INC.

Contrast medium injection system syringe
Primary Device ID30841716101633
NIH Device Record Key2116da28-f734-4b0b-96d6-1ad9def5fceb
Commercial Distribution StatusIn Commercial Distribution
Brand NameMulti-use Syringe Kit
Version Model Number014113
Company DUNS926684994
Company NameACIST MEDICAL SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110841716101639 [Primary]
GS130841716101633 [Package]
Contains: 10841716101639
Package: [10 Units]
In Commercial Distribution

FDA Product Code

DXTInjector And Syringe, Angiographic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-04-20
Device Publish Date2019-05-06

On-Brand Devices [Multi-use Syringe Kit]

30841716101633Model A2000V, p/n 701259-006 Kit Contents: 100mL contrast reservoir and tubing with contrast spi
30841716100087Model A2000V, p/n 701259-003 Kit Contents: 100mL contrast reservoir and tubing with contrast spi

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