Duns Number:011920774
Catalog Number
-
Brand Name
Quality Choice
Version/Model Number
BP3AQ1-1CDMA(96678)
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
-
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
cf73e2b0-8fff-4042-a6e1-26057198965d
Public Version Date
November 08, 2019
Public Version Number
3
DI Record Publish Date
October 18, 2016
Package DI Number
10635515966786
Quantity per Package
12
Contains DI Package
00635515966789
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton packing
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 10 |