Duns Number:116961530
Device Description: Cellular connected (Cat-M) non-invasive blood pressure monitor.
Catalog Number
-
Brand Name
Pylo Health
Version/Model Number
PY-802-LTE
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
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
8bf394c6-2582-452e-bd96-054df41dc36d
Public Version Date
September 09, 2020
Public Version Number
1
DI Record Publish Date
September 01, 2020
Package DI Number
10860004709500
Quantity per Package
10
Contains DI Package
00860004709503
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |