Catalog Number

-

Brand Name

Centurion

Version/Model Number

CVI2025

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code

LRS

Product Code Name

I.V. start kit

Public Device Record Key

0e14380f-fc7f-420c-ac89-c8c80dd5ff50

Public Version Date

December 11, 2019

Public Version Number

4

DI Record Publish Date

August 14, 2017

Package DI Number

50653160060459

Quantity per Package

12

Contains DI Package

00653160060454

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE