Catalog Number

-

Brand Name

Changke Connect

Version/Model Number

CK-SMD-582A1-05AR2

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

K191428

Product Code

DSA

Product Code Name

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

Public Device Record Key

c487b0ea-6fad-4007-9282-f3b8223056a2

Public Version Date

November 10, 2020

Public Version Number

1

DI Record Publish Date

November 02, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-