Duns Number:078497467
Device Description: BM47 Universal Cuff (replacement)
Catalog Number
-
Brand Name
Beurer
Version/Model Number
BM47 Universal Cuff (replacement)
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
b7f466cc-3354-440a-909b-500d8a436663
Public Version Date
November 08, 2019
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
10852547004600
Quantity per Package
20
Contains DI Package
00852547004603
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 |