Duns Number:145581588
Device Description: Ambulatory Blood Pressure Monitor
Catalog Number
N/A
Brand Name
ABP
Version/Model Number
90217
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 30, 2017
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
-
Product Code
DXN
Product Code Name
SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
Public Device Record Key
c98e78a1-17ad-48c2-9d47-364b81f46798
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
December 13, 2016
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 | 18 |
2 | A medical device with a moderate to high risk that requires special controls. | 732 |