Catalog Number

-

Brand Name

Neusite

Version/Model Number

NC5000

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

399f5c93-95df-4315-9637-a16bcc2aa721

Public Version Date

April 07, 2021

Public Version Number

3

DI Record Publish Date

August 06, 2018

Package DI Number

55019517133187

Quantity per Package

36

Contains DI Package

35019517133183

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case