Catalog Number

SF200S

Brand Name

SafeFill

Version/Model Number

Small 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

3995dbce-dd91-463b-9555-3a21027e0b49

Public Version Date

March 07, 2022

Public Version Number

5

DI Record Publish Date

March 08, 2017

Package DI Number

00854989006047

Quantity per Package

50

Contains DI Package

00854989006030

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box