Duns Number:273647420
Device Description: ABX PENTRA 400 ISE (110V)
Catalog Number
-
Brand Name
ABX PENTRA 400 ISE
Version/Model Number
1280030045
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
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
K052007
Product Code
JJE
Product Code Name
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Public Device Record Key
2d1f9679-dd51-4083-8b34-d9256aebff0b
Public Version Date
September 16, 2022
Public Version Number
5
DI Record Publish Date
September 02, 2016
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 | 104 |
2 | A medical device with a moderate to high risk that requires special controls. | 100 |