Duns Number:966632304
Device Description: A Health Harmony Kit contains the components of the Health Harmony Remote Patient Monitori A Health Harmony Kit contains the components of the Health Harmony Remote Patient Monitoring system that are needed by the patient. A Health Harmony Mobile Kit contains a personal mobile device pre-loaded with Health Harmony Mobile software that has been setup for the patient. The kit will also contain any Bluetooth medical devices (e.g. a weight scale or a pulse oximeter) that have been selected by the healthcare provider for remote collection of patient vital signs.
Catalog Number
-
Brand Name
Health Harmony
Version/Model Number
Kit RPM - Mobile
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"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
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Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
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FDA Premarket Submission
-
Product Code
-
Product Code Name
-
Public Device Record Key
7116f8b1-a114-4b85-a3a1-89ad8ab1a5f8
Public Version Date
October 10, 2022
Public Version Number
2
DI Record Publish Date
September 28, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |