Catalog Number

700-60401

Brand Name

EKOS™ CU 4-0 Cart

Version/Model Number

700-60401

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

-

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

FOX

Product Code Name

STAND, INFUSION

Public Device Record Key

31db1ade-0f24-4823-aff9-560a60bcc56a

Public Version Date

September 28, 2021

Public Version Number

1

DI Record Publish Date

September 20, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-