Catalog Number

-

Brand Name

EZ Regular

Version/Model Number

N110

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

K080303,K080303,K080303

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

704402ea-26f1-4354-aa7a-082dde5b2d9f

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

November 29, 2016

Package DI Number

38809289430101

Quantity per Package

10

Contains DI Package

28809289430098

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-