Catalog Number

-

Brand Name

OnGuard®2 CSTD 28mm Vial Adaptor

Version/Model Number

412162

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

e0d995d7-df8e-4033-bbdf-5810ea1f8e16

Public Version Date

September 25, 2020

Public Version Number

2

DI Record Publish Date

July 12, 2020

Package DI Number

37290115921626

Quantity per Package

4

Contains DI Package

27290115921629

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-