Catalog Number

LL-2S

Brand Name

Equashield

Version/Model Number

Luer Lock Adaptor Spinlock

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

-

Product Code

ONB

Product Code Name

Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

Public Device Record Key

06d5728c-754d-477c-9f68-8433b73c6f7e

Public Version Date

December 13, 2021

Public Version Number

1

DI Record Publish Date

December 05, 2021

Package DI Number

17290013484601

Quantity per Package

120

Contains DI Package

07290013484604

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX