Catalog Number

-

Brand Name

NeutrArt®

Version/Model Number

AU1010NL35

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

K201872,K201872

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

9a8cee2c-2629-4f83-910d-d78e2764e832

Public Version Date

May 09, 2022

Public Version Number

1

DI Record Publish Date

April 29, 2022

Package DI Number

28699443585449

Quantity per Package

50

Contains DI Package

08699443585445

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box