Duns Number:052423787
Device Description: Osmocoll HNL Osmolality Controls are for use as controls for osmolality determination by a Osmocoll HNL Osmolality Controls are for use as controls for osmolality determination by a vapor pressure osmometer.
Catalog Number
-
Brand Name
OSMOCOLL® HNL osmolality Controls, 6x1mL
Version/Model Number
SS-273
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
JJY
Product Code Name
Multi-Analyte Controls, All Kinds (Assayed)
Public Device Record Key
b552b1ff-7aef-42a2-bf9c-87c8e39d336a
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 |