Duns Number:227530649
Device Description: The product is intended to be used as a wash solution and single point calibrator. Calibr The product is intended to be used as a wash solution and single point calibrator. Calibrator A is pumped into the sample port by the Calibrator A pump and then positioned in front of the sensor.
Catalog Number
RX4000
Brand Name
CAL A
Version/Model Number
RX4000
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K024014
Product Code
JIX
Product Code Name
Calibrator, Multi-Analyte Mixture
Public Device Record Key
dea32ea0-6cd8-4533-aca7-5d6eb9b9966b
Public Version Date
December 21, 2020
Public Version Number
4
DI Record Publish Date
September 26, 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 | 305 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 258 |