Duns Number:078497467
Device Description: Wrist Blood Pressure Monitor
Catalog Number
Type BC30/1
Brand Name
Beurer
Version/Model Number
BC30 (Art.-No.650.70)
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
2482a5b8-1e0f-43c9-8fbb-ca7f0c7d5f48
Public Version Date
November 08, 2019
Public Version Number
4
DI Record Publish Date
March 27, 2017
Package DI Number
20852547004690
Quantity per Package
8
Contains DI Package
10852547004693
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 |