Duns Number:006959555
Device Description: Meijer Automatic Digital BP Unit
Catalog Number
74-5021
Brand Name
Meijer
Version/Model Number
74-5021
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
-
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
b27c7a14-02ec-4130-8717-6c8fa60ab3cf
Public Version Date
November 08, 2019
Public Version Number
3
DI Record Publish Date
September 15, 2016
Package DI Number
30760236653364
Quantity per Package
2
Contains DI Package
00760236653363
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Intermediate
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 |