CPT2000 Automated Manifold Kit

GUDID 30841716100346

Model CPT2000 p/n 701324-004 Kit Contents: manifold with saline and contrast ports, saline tubing with spike and hand syringe

ACIST MEDICAL SYSTEMS, INC.

Contrast medium injection system administration set
Primary Device ID30841716100346
NIH Device Record Key07be17b7-c12c-4591-ac5c-14bfabe819e8
Commercial Distribution Discontinuation2018-05-21
Commercial Distribution StatusNot in Commercial Distribution
Brand NameCPT2000 Automated Manifold Kit
Version Model Number014623
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110841716100342 [Primary]
GS130841716100346 [Package]
Contains: 10841716100342
Package: Shelf box [10 Units]
Discontinued: 2018-05-21
Not 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 Number4
Public Version Date2021-02-19
Device Publish Date2016-09-09

On-Brand Devices [CPT2000 Automated Manifold Kit]

30841716100339Model CPT2000 p/n 701324-002 Kit Contents: manifold with saline and contrast ports, saline tubin
30841716100346Model CPT2000 p/n 701324-004 Kit Contents: manifold with saline and contrast ports, saline tubin

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