Catalog Number

SF100

Brand Name

SafeFill

Version/Model Number

Universal Vial Adapter

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K921031,K921031

Product Code

LHI

Product Code Name

Set, I.V. Fluid Transfer

Public Device Record Key

9f89d6dc-d21f-44ca-8557-e76d46bc61dc

Public Version Date

March 07, 2022

Public Version Number

5

DI Record Publish Date

March 09, 2017

Package DI Number

00854989006139

Quantity per Package

50

Contains DI Package

00854989006061

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box