Catalog Number

AD-BA-10

Brand Name

Caremed

Version/Model Number

AD-BA-10

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 30, 2019

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

K153188

Product Code

DSA

Product Code Name

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

Public Device Record Key

56b47c89-47e7-4a82-8460-2d3409051be4

Public Version Date

November 07, 2019

Public Version Number

1

DI Record Publish Date

October 30, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-