Duns Number:078497467
Device Description: UPPER ARM BLOOD PRESSURE MONITOR (with cuff 22-42 cm).
Catalog Number
656.69
Brand Name
Beurer
Version/Model Number
BM31
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
f9c929f7-78e2-47f0-85f0-306b2f43cf62
Public Version Date
September 07, 2020
Public Version Number
2
DI Record Publish Date
July 31, 2020
Package DI Number
10850018808016
Quantity per Package
6
Contains DI Package
00850018808019
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Pack
| 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 |