Catalog Number

10A1071

Brand Name

uCor Heart Failure and Arrhythmia Management System

Version/Model Number

Sensor

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K172510

Product Code

DSB

Product Code Name

Plethysmograph, Impedance

Public Device Record Key

8d6e1e26-2a9d-48fb-83ed-f0c91fc94f40

Public Version Date

November 10, 2021

Public Version Number

4

DI Record Publish Date

May 17, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-