Catalog Number

-

Brand Name

HeartsCare C1 multi-functional monitoring system

Version/Model Number

TD-4289

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

NBW

Product Code Name

System, Test, Blood Glucose, Over The Counter

Public Device Record Key

ac1da8d0-61bd-427a-9303-df23d90c9c4f

Public Version Date

February 03, 2022

Public Version Number

1

DI Record Publish Date

January 26, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-