Catalog Number

UE-5140-102-00

Brand Name

IntelliCart™

Version/Model Number

UE-5140-102-00

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)

Yes

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

JCX

Product Code Name

APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Public Device Record Key

b23efdfb-a46c-42ce-8f98-6b96ac2455f5

Public Version Date

August 24, 2021

Public Version Number

5

DI Record Publish Date

February 01, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-