Duns Number:063997360
Device Description: LDR Blood Pressure Home Kit with manual Stethoscope
Catalog Number
5279823
Brand Name
Leader
Version/Model Number
5279823
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K082542,K082542,K082542
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
8d5770e6-78af-482b-8a2b-862d1922d01e
Public Version Date
July 05, 2021
Public Version Number
4
DI Record Publish Date
March 23, 2017
Package DI Number
50096295129323
Quantity per Package
4
Contains DI Package
30096295129329
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 23 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 39 |