Duns Number:070617139
Device Description: GLUCOSE/BUN OVER-RANGE SOLUTION
Catalog Number
13177
Brand Name
Nova
Version/Model Number
1
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
K963005,K963005
Product Code
JJY
Product Code Name
Multi-analyte controls, all kinds (assayed)
Public Device Record Key
c124ca39-4ed8-4c04-93eb-d63b6e2f2d59
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 20, 2016
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 | 165 |
2 | A medical device with a moderate to high risk that requires special controls. | 210 |