Catalog Number

-

Brand Name

IV Administration Set

Version/Model Number

7052

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

59de1935-f8b1-4dd3-a871-465f9f5f8fd8

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

00616784705231

Quantity per Package

4

Contains DI Package

00616784705224

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-