Duns Number:006959555
Device Description: Meijer Ultra Premium Automatic Arm Digital BP Monitor
Catalog Number
74-509
Brand Name
MEIJER
Version/Model Number
74-509
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
-
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
dcb2d2b6-2d0b-4af8-9ac7-57851d0ed587
Public Version Date
November 08, 2019
Public Version Number
2
DI Record Publish Date
August 31, 2018
Package DI Number
10713733353943
Quantity per Package
12
Contains DI Package
30713733353947
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
MASTER SHIPPER
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 37 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 45 |
| U | Unclassified | 1 |