Duns Number:319441788
Device Description: OSMOREF® Reference Solution is intended for use in evaluating the performance of customer OSMOREF® Reference Solution is intended for use in evaluating the performance of customer osmometers. It is an independent reference for checking the linearity of the instrument in the osmolality range of normal serum.
Catalog Number
30.9.0290
Brand Name
GONOTEC Reference Solution OSMOREF® 290 mOsmol/kg, 10x1ml
Version/Model Number
30.9.0290
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)
-
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
469b4059-ab40-481e-881b-3024a2b9d732
Public Version Date
May 17, 2021
Public Version Number
1
DI Record Publish Date
May 07, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |