Catalog Number

-

Brand Name

Rhythmlink®

Version/Model Number

SP210001

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

Yes

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

-

Product Code

IKD

Product Code Name

Cable, Electrode

Public Device Record Key

16df4776-add8-4061-a47c-2d0dcab8dfef

Public Version Date

August 16, 2021

Public Version Number

1

DI Record Publish Date

August 06, 2021

Package DI Number

10816312025917

Quantity per Package

24

Contains DI Package

00816312025910

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Product Box