Catalog Number

N/A

Brand Name

My Dose Coach

Version/Model Number

2.x.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

K163099,K171230,K163099,K171230

Product Code

NDC

Product Code Name

Calculator, drug dose

Public Device Record Key

6bfb173e-c31a-4d91-b6f7-acde26be48b6

Public Version Date

October 24, 2022

Public Version Number

3

DI Record Publish Date

November 23, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-