Catalog Number

-

Brand Name

CORE Mobile System Medical Equipment 100V

Version/Model Number

400-0100.08

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

K123898

Product Code

DSA

Product Code Name

Cable, Transducer And Electrode, Patient, (Including Connector)

Public Device Record Key

c405a862-e4c5-4f89-8f97-1b9d20b6f2cb

Public Version Date

February 28, 2022

Public Version Number

5

DI Record Publish Date

September 12, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-