Catalog Number

00021

Brand Name

ECG cable

Version/Model Number

X

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

-

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

K014063

Product Code

DSB

Product Code Name

Plethysmograph, Impedance

Public Device Record Key

c38cfee7-3459-42a7-b9c2-695bc86d2365

Public Version Date

November 10, 2021

Public Version Number

4

DI Record Publish Date

November 28, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-