Catalog Number

K3131

Brand Name

Dimension Vista® Flex® reagent cartridge LDLC

Version/Model Number

10445096

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K061655,K061655

Product Code

MRR

Product Code Name

SYSTEM, TEST, LOW DENSITY, LIPOPROTEIN

Public Device Record Key

c7988ac6-4e6d-40da-8711-76c4d106f8e3

Public Version Date

November 18, 2021

Public Version Number

2

DI Record Publish Date

September 24, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-