Catalog Number

-

Brand Name

OnGuard®2 CSTD 20mm Vial Adaptor and 13mm Convertor

Version/Model Number

412161

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

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

K192866,K192866,K192866

Product Code

ONB

Product Code Name

Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

Public Device Record Key

32d2ba8d-f191-4f94-aabf-cd3843bc564b

Public Version Date

September 25, 2020

Public Version Number

2

DI Record Publish Date

July 09, 2020

Package DI Number

37290115921619

Quantity per Package

4

Contains DI Package

27290115921612

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-