Duns Number:008965063
Device Description: WALG PREM WRIST BP MNTR B/T 2016
Catalog Number
WGNBPW-930BT
Brand Name
Well at Walgreens
Version/Model Number
WGNBPW-930BT
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
K160557,K160557
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
fca64bf3-f071-4948-bc48-02bfdd45ac70
Public Version Date
November 08, 2019
Public Version Number
4
DI Record Publish Date
September 15, 2016
Package DI Number
10311917183388
Quantity per Package
6
Contains DI Package
00311917183381
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 75 |
2 | A medical device with a moderate to high risk that requires special controls. | 74 |
U | Unclassified | 2 |