Catalog Number

-

Brand Name

Equashield

Version/Model Number

Equashield Accessories

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

9358e3f2-24d8-491b-ba1e-2320fb92afed

Public Version Date

May 13, 2019

Public Version Number

3

DI Record Publish Date

May 16, 2016

Package DI Number

27290013484417

Quantity per Package

80

Contains DI Package

07290013484413

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-