Catalog Number

-

Brand Name

MediChoice

Version/Model Number

DCL40002

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K142489,K142489,K142489

Product Code

DSA

Product Code Name

CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Public Device Record Key

f0e02abd-c3a3-42af-9b99-2d0e47b6e9e5

Public Version Date

September 17, 2019

Public Version Number

1

DI Record Publish Date

September 09, 2019

Package DI Number

30885632256015

Quantity per Package

20

Contains DI Package

20885632256018

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-