Catalog Number

-

Brand Name

Little PALS

Version/Model Number

SEN4001

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 16, 2020

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

K000206

Product Code

DRX

Product Code Name

Electrode, Electrocardiograph

Public Device Record Key

c3366cbb-47fa-47d5-8c1e-1419a5749d9e

Public Version Date

March 16, 2022

Public Version Number

4

DI Record Publish Date

March 31, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-