Duns Number:051957769
Catalog Number
-
Brand Name
ReliOn BP300W Wrist Blood Pressure Monitor
Version/Model Number
6021RELN2
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K131742,K131742
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
02a58c49-06f2-4b46-a131-2eca48322293
Public Version Date
November 08, 2019
Public Version Number
4
DI Record Publish Date
September 20, 2016
Package DI Number
10605388577228
Quantity per Package
10
Contains DI Package
00605388577221
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 | 22 |
2 | A medical device with a moderate to high risk that requires special controls. | 76 |