Duns Number:657836743
Device Description: wrist type blood pressure monitor
Catalog Number
-
Brand Name
Walgreens
Version/Model Number
WGNBPW-910
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
K160336,K160336
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
c9e47a15-43c5-4bab-a72e-161a3e751935
Public Version Date
November 08, 2019
Public Version Number
4
DI Record Publish Date
June 13, 2016
Package DI Number
14719872480010
Quantity per Package
12
Contains DI Package
04719872480013
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 |