Duns Number:537208717
Device Description: RBP-100 is a non-invasive blood pressure monitors for measuring at the upper arm
Catalog Number
1743
Brand Name
RBP-100 Blutdruckmessgerät Rail Modell
Version/Model Number
1743
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K190927
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
f5f46853-7835-4bdd-b7a8-b9eae3420c10
Public Version Date
February 05, 2021
Public Version Number
1
DI Record Publish Date
January 28, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 282 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 332 |