Duns Number:125006353
Device Description: Built to keep the busiest labs productive, the A2O Advanced Automated Osmometer combines e Built to keep the busiest labs productive, the A2O Advanced Automated Osmometer combines exceptional analytical performance with full automation. Laboratories can depend on the A2O to deliver accurate and precise osmolality measurements while maximizing walk-away time.
Catalog Number
A2O
Brand Name
A20 Advanced Automated Osmometer
Version/Model Number
A2O
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
-
Product Code
JJM
Product Code Name
Osmometer For Clinical Use
Public Device Record Key
8c621409-6406-4add-96a0-9c959614ad82
Public Version Date
September 16, 2022
Public Version Number
2
DI Record Publish Date
September 21, 2020
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 | 50 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 21 |