Catalog Number

0485801

Brand Name

Additive

Version/Model Number

485801

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"

Yes

For Single-Use

-

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

-

Product Code

KPE

Product Code Name

CONTAINER, I.V.

Public Device Record Key

3710fa68-36fa-4ad4-923e-eb33daa027fe

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

September 20, 2016

Package DI Number

20887787001871

Quantity per Package

10

Contains DI Package

10887787001874

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case