Duns Number:043081723
Device Description: Advocate Wrist BPM W/Color Indicator
Catalog Number
404
Brand Name
Advocate Wrist BPM W/Color Indicator
Version/Model Number
KD-7902
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
e0a31685-bb03-4170-9f4c-597202c65bce
Public Version Date
May 27, 2020
Public Version Number
6
DI Record Publish Date
August 22, 2016
Package DI Number
10894046001230
Quantity per Package
10
Contains DI Package
00894046001233
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
404-C
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 6 |