Catalog Number

-

Brand Name

Neusite

Version/Model Number

NC5011B

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

-

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

86cc12f7-fe50-478b-bc40-4d7156076b5e

Public Version Date

September 06, 2018

Public Version Number

1

DI Record Publish Date

August 06, 2018

Package DI Number

55019517133194

Quantity per Package

36

Contains DI Package

35019517133190

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case