Duns Number:052423787
Device Description: ELITechGroup's Opti-Mole solution is for calibration of the Vapro Vapor Pressure Osmometer ELITechGroup's Opti-Mole solution is for calibration of the Vapro Vapor Pressure Osmometer.
Catalog Number
-
Brand Name
OPTIMOLE™ Osmolality Standard, 1000 mmol/kg, 60x.4mL
Version/Model Number
OA-100
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
JIS
Product Code Name
Calibrator, Primary
Public Device Record Key
dd3db97d-fab2-4d40-bf2b-562b0a768b6d
Public Version Date
March 01, 2021
Public Version Number
1
DI Record Publish Date
February 19, 2021
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 | 26 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 41 |