Catalog Number

-

Brand Name

IV Adminstration Set

Version/Model Number

7046

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

K083687

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

c62f54e9-6c3b-4b68-a0a8-0eec072a6dae

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

January 06, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-