Duns Number:657836743
Device Description: Arm Type blood pressure monitor
Catalog Number
-
Brand Name
HoMedics
Version/Model Number
BPA-065
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
K050491,K050491
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
60872fad-4fd6-410b-852c-6d3e9f955aca
Public Version Date
November 08, 2019
Public Version Number
2
DI Record Publish Date
April 01, 2019
Package DI Number
14719872483233
Quantity per Package
4
Contains DI Package
04719872483236
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 37 |