Duns Number:049283340
Catalog Number
-
Brand Name
caring mill
Version/Model Number
BP3NC1-2AFSA
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
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
4f020fe0-45cc-4e64-9125-ab358b313902
Public Version Date
November 08, 2019
Public Version Number
3
DI Record Publish Date
January 29, 2018
Package DI Number
50861618000326
Quantity per Package
12
Contains DI Package
00861618000321
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box packing
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 16 |