Duns Number:145581588
Device Description: Ambulatory Blood Pressure (ABP) Report Management System
Catalog Number
N/A
Brand Name
ABP
Version/Model Number
92506
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 15, 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
7622551a-5399-4316-8b2f-130edcf23243
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 11, 2017
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 |