Duns Number:554511666
Catalog Number
-
Brand Name
agelh
Version/Model Number
BA-802X
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K193627,K193627
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
20a784b6-6b09-410a-9068-1e95aff75f53
Public Version Date
December 27, 2021
Public Version Number
3
DI Record Publish Date
December 17, 2020
Package DI Number
16973826010564
Quantity per Package
24
Contains DI Package
06973826010567
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-