Duns Number:008965063
Device Description: WALG AUTO WRIST 2017 W/WINDOW PKG
Catalog Number
WGNBPW-915
Brand Name
Well at Walgreens
Version/Model Number
WGNBPW-915
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
774b372b-39bb-4085-985f-fedbf26fb591
Public Version Date
November 08, 2019
Public Version Number
4
DI Record Publish Date
October 09, 2017
Package DI Number
10311917194643
Quantity per Package
12
Contains DI Package
00311917194646
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 |