Catalog Number

-

Brand Name

Vial Adaptor

Version/Model Number

8072003

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

K963583,K963583,K963583

Product Code

LHI

Product Code Name

Set, I.V. Fluid Transfer

Public Device Record Key

f475f2d0-5e42-4409-9fc6-be409666b3c7

Public Version Date

July 23, 2020

Public Version Number

7

DI Record Publish Date

May 01, 2016

Package DI Number

27290108240171

Quantity per Package

4

Contains DI Package

17290108240174

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-