Duns Number:007924756
Catalog Number
-
Brand Name
HEB in Control
Version/Model Number
BP3NU1-3ZHEB
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
fa718648-178b-4bdb-83e8-2fa253c05552
Public Version Date
May 14, 2020
Public Version Number
1
DI Record Publish Date
May 06, 2020
Package DI Number
10041220140722
Quantity per Package
12
Contains DI Package
00041220140725
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 23 |
2 | A medical device with a moderate to high risk that requires special controls. | 32 |