Duns Number:006959555
Device Description: Meijer Premium Display Arm Cuff DBPM with Clamp Cuff
Catalog Number
74-561
Brand Name
Meijer
Version/Model Number
74-561
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
eeffed5f-11fe-4a37-9189-da4b8d953147
Public Version Date
November 08, 2019
Public Version Number
3
DI Record Publish Date
September 15, 2016
Package DI Number
30708820058782
Quantity per Package
3
Contains DI Package
00708820058781
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 |