Health Optimizer - Health Optimizer® is indicated for use by - WELLDOC, INC.

Duns Number:021217115

Device Description: Health Optimizer® is indicated for use by healthcare providers (HCPs) and their patients –

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More Product Details

Catalog Number

-

Brand Name

Health Optimizer

Version/Model Number

v1.3

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K193654

Product Code Details

Product Code

MRZ

Product Code Name

Accessories, Pump, Infusion

Device Record Status

Public Device Record Key

b1542492-f100-4b33-b679-4f58adeecad5

Public Version Date

October 24, 2022

Public Version Number

2

DI Record Publish Date

August 04, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WELLDOC, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 56