Duns Number:831996595
Device Description: Description: 5% CO2, BAL. N2;Cylinder: BD8;Valve: K-28;For calibration of medical analyz Description: 5% CO2, BAL. N2;Cylinder: BD8;Valve: K-28;For calibration of medical analyzers in accordance with manufacturer's instructions.
Catalog Number
Z02NI958BDC002
Brand Name
Nonin Medical
Version/Model Number
Calibration Gas
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
BXK
Product Code Name
Gas, Calibration (Specified Concentration)
Public Device Record Key
530f8c6e-cc43-4c50-a127-b4e8dcb667c2
Public Version Date
November 18, 2019
Public Version Number
1
DI Record Publish Date
November 10, 2019
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 | 281 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |