Duns Number:021217115
Device Description: Health Optimizer® Rx is indicated for use by healthcare providers (HCPs) and their patient
Catalog Number
-
Brand Name
Health Optimizer Rx
Version/Model Number
v1.2
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 04, 2022
Issuing Agency
In HIBCC
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
K193654
Product Code
MRZ
Product Code Name
Accessories, Pump, Infusion
Public Device Record Key
ff846776-3061-41a2-9d43-f6b7b8a3b8d4
Public Version Date
October 24, 2022
Public Version Number
3
DI Record Publish Date
May 20, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 56 |