Duns Number:078497467
Device Description: Upper Arm Blood Pressure Monitor
Catalog Number
652.72
Brand Name
Beurer
Version/Model Number
BM26
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"
Yes
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
48733e1e-1462-4e42-a0d0-079c0579d197
Public Version Date
November 17, 2020
Public Version Number
6
DI Record Publish Date
September 24, 2016
Package DI Number
10852547004709
Quantity per Package
4
Contains DI Package
00852547004702
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 | 7 |
2 | A medical device with a moderate to high risk that requires special controls. | 90 |
U | Unclassified | 2 |