Catalog Number

-

Brand Name

Mindray

Version/Model Number

A-CO-183

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

IKD

Product Code Name

Cable, Electrode

Public Device Record Key

557ef0f9-4733-450c-86a5-afd3897df8cb

Public Version Date

November 03, 2021

Public Version Number

3

DI Record Publish Date

May 28, 2021

Package DI Number

16946725590642

Quantity per Package

25

Contains DI Package

06946725529041

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-