Catalog Number

-

Brand Name

Set, I.V. Fluid Transfer

Version/Model Number

SM-016

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LHI

Product Code Name

Set, I.V. Fluid Transfer

Public Device Record Key

c1776d21-23b3-49a1-81c6-dc3a736f7d61

Public Version Date

February 19, 2021

Public Version Number

5

DI Record Publish Date

June 09, 2016

Package DI Number

10816513022296

Quantity per Package

50

Contains DI Package

00816513022299

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX