Duns Number:078497467
Device Description: Bluetooth® Upper Arm Blood Pressure Monitor* with cuff size 8.7 - 17.3 in (22 - 44 cm)
Catalog Number
Art.- No 659.697
Brand Name
Beurer
Version/Model Number
BM76
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
030e5f22-d2c8-44b0-a76a-781bb698e113
Public Version Date
November 08, 2019
Public Version Number
2
DI Record Publish Date
March 12, 2019
Package DI Number
10850003500031
Quantity per Package
6
Contains DI Package
00850003500034
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 |