Catalog Number

-

Brand Name

Nfuze

Version/Model Number

PRS401

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 12, 2022

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K210381

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

1b3c3a0b-9c7b-48e3-a030-430643eab38c

Public Version Date

October 10, 2022

Public Version Number

3

DI Record Publish Date

May 17, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-