Catalog Number

-

Brand Name

Vial Adaptor

Version/Model Number

8070311

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

Product Code

LHI

Product Code Name

Set, I.V. Fluid Transfer

Public Device Record Key

b70274e9-f63e-40be-acb1-6f31c614ac9e

Public Version Date

July 23, 2020

Public Version Number

8

DI Record Publish Date

May 01, 2016

Package DI Number

27290108240478

Quantity per Package

1500

Contains DI Package

07290108240474

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-