Duns Number:315028860
Device Description: proBNP G2 CS Elecsys E2G V2.1
Catalog Number
09315314190
Brand Name
Elecsys proBNP II CalSet
Version/Model Number
09315314190
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JIT
Product Code Name
Calibrator, secondary
Public Device Record Key
927fed02-29fe-49da-94b5-5a74bf9ee415
Public Version Date
May 16, 2022
Public Version Number
1
DI Record Publish Date
May 07, 2022
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 | 289 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 760 |
| 3 | A medical device with high risk that requires premarket approval | 63 |
| U | Unclassified | 4 |