Duns Number:176387785
Catalog Number
-
Brand Name
RITE AID
Version/Model Number
BPAG1-20RITE
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K193259,K193259
Product Code
DXQ
Product Code Name
Blood Pressure Cuff
Public Device Record Key
c5a3e2f1-a27a-4e9e-a117-16f10d6a4d25
Public Version Date
January 17, 2022
Public Version Number
1
DI Record Publish Date
January 07, 2022
Package DI Number
10011822589946
Quantity per Package
12
Contains DI Package
00011822589949
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. | 27 |