Catalog Number

-

Brand Name

OnGuard 2 CSTD Bag Adaptor SP with ULTRASITE

Version/Model Number

412146

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

K201142,K201142

Product Code

ONB

Product Code Name

Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

Public Device Record Key

8cfbb9ec-9125-4acd-b121-d77a143d2958

Public Version Date

March 19, 2021

Public Version Number

1

DI Record Publish Date

March 11, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-