Catalog Number

-

Brand Name

IV Administration Set

Version/Model Number

7037

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)

Yes

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

K012189,K012189,K012189

Product Code

LHI

Product Code Name

Set, I.V. Fluid Transfer

Public Device Record Key

9eafabd2-b4fe-4979-b741-a4873abb505a

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

00616784703732

Quantity per Package

4

Contains DI Package

00616784703725

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-