Catalog Number

-

Brand Name

12Pin 12-Lead Host Cable

Version/Model Number

040-003528-00

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"

-

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

K182075

Product Code

DRW

Product Code Name

Adaptor, Lead Switching, Electrocardiograph

Public Device Record Key

e65db15f-d3df-4f3f-bea2-c23a37073489

Public Version Date

May 07, 2020

Public Version Number

1

DI Record Publish Date

April 29, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-