Catalog Number

-

Brand Name

Rhythmlink®

Version/Model Number

RLSPGSP120

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

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

7e551990-4023-4b02-847c-ff2457b659cb

Public Version Date

November 04, 2021

Public Version Number

1

DI Record Publish Date

October 27, 2021

Package DI Number

10816312026075

Quantity per Package

40

Contains DI Package

00816312026085

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-