Duns Number:132016168
Device Description: Home Blood Pressure Kit
Catalog Number
-
Brand Name
LabTron
Version/Model Number
242
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K092245,K092245
Product Code
DXQ
Product Code Name
Blood Pressure Cuff
Public Device Record Key
aab97de0-99a0-4095-a7f0-b31cd610f350
Public Version Date
July 25, 2019
Public Version Number
4
DI Record Publish Date
August 31, 2016
Package DI Number
M3682422
Quantity per Package
24
Contains DI Package
M3682421
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1068 |
2 | A medical device with a moderate to high risk that requires special controls. | 202 |