Duns Number:078497467
Device Description: Upper Arm Blood Pressure Monitor* with cuff size 8.7 - 16.5 in (22 - 42 cm)
Catalog Number
Art.- No 658.78
Brand Name
Beurer
Version/Model Number
BM55
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
d39965d9-b57b-4a76-9b6a-c697b9983c75
Public Version Date
November 08, 2019
Public Version Number
3
DI Record Publish Date
June 11, 2018
Package DI Number
20852547004287
Quantity per Package
4
Contains DI Package
10852547004280
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case 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 |