Catalog Number

-

Brand Name

Equashield

Version/Model Number

Equashield Reconstitution Set

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

ONB

Product Code Name

Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

Public Device Record Key

ff2521e9-3810-46ec-a978-50f88a405fd3

Public Version Date

May 20, 2019

Public Version Number

1

DI Record Publish Date

May 12, 2019

Package DI Number

27290013484424

Quantity per Package

80

Contains DI Package

07290013484420

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-