Catalog Number

CK-5

Brand Name

Equashield

Version/Model Number

Equashield Convenience Kit

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

-

Product Code Name

-

Public Device Record Key

e7196ae3-f1ed-49bd-8faf-f0dfd162805b

Public Version Date

May 20, 2019

Public Version Number

1

DI Record Publish Date

May 12, 2019

Package DI Number

37290013484513

Quantity per Package

8

Contains DI Package

17290013484519

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-