Duns Number:417870361
Device Description: This is an arm type blood pressure monitor.This monitor features blood pressure measuremen This is an arm type blood pressure monitor.This monitor features blood pressure measurement,pulse rate measurement and the result storage.
Catalog Number
-
Brand Name
Vigorun
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"
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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
22808cf9-b201-4d1b-a82e-45c02e802adb
Public Version Date
June 19, 2020
Public Version Number
1
DI Record Publish Date
June 11, 2020
Package DI Number
36972797033002
Quantity per Package
18
Contains DI Package
06972797033001
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton