Catalog Number

-

Brand Name

Vial Adapter

Version/Model Number

8070013

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"

-

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

K001293,K001293

Product Code

LHI

Product Code Name

Set, I.V. Fluid Transfer

Public Device Record Key

51f3de15-6ce8-4a98-89f2-a9c6a3e727f2

Public Version Date

July 23, 2020

Public Version Number

7

DI Record Publish Date

March 19, 2017

Package DI Number

27290108240560

Quantity per Package

1500

Contains DI Package

07290108240566

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-