Duns Number:658023275
Device Description: The product automatically measures human begins Systolic, Diastolic blood pressure and pul The product automatically measures human begins Systolic, Diastolic blood pressure and pulse rate by oscillometric method. The measurement results are displayed on the LCD. Measurement position is at human being's wrist. The intended use of this over-the-counter device is for adults with wrist circumference ranging from 125 mm to 210 mm (Approx.4.9 ~ 8.3 inches) and for home use. When the device detects the appearance of irregular heartbeats such as atrial or ventricular premature beats during measurement, an indicated symbol will appear with measuring readings. This device is designed only for adults.
Catalog Number
-
Brand Name
Harbor Freight Tools
Version/Model Number
58460
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
-
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
640cc804-4fdf-45fa-9d60-50e61d5080c6
Public Version Date
October 21, 2020
Public Version Number
1
DI Record Publish Date
October 13, 2020
Package DI Number
04710953421635
Quantity per Package
24
Contains DI Package
04710953421628
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Paper box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |