Duns Number:417870361
Device Description: This is an arm type blood pressure monitor.The monitor features blood pressure measurement This is an arm type blood pressure monitor.The monitor features blood pressure measurement, pulse rate measurement and the result storage.
Catalog Number
-
Brand Name
Blood Pressure Monitor
Version/Model Number
TMB-1583-S
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
K120058,K120058
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
3529fde2-bb76-4fec-8e24-8b54019373be
Public Version Date
November 27, 2019
Public Version Number
1
DI Record Publish Date
November 19, 2019
Package DI Number
36972797030117
Quantity per Package
18
Contains DI Package
06972797030116
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton