Duns Number:227530649
Device Description: This should be run once a day to prevent protein build up or at 8 hour intervals if the IS This should be run once a day to prevent protein build up or at 8 hour intervals if the ISE module performs more than 50 samples per day. Cleaning solution may be aspirated from a sample cup but the cup must be covered between use to eliminate evaporation and ensure accuracy.
Catalog Number
RX4003
Brand Name
SOLN WASH
Version/Model Number
RX4003
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
JJF
Product Code Name
Analyzer, Chemistry, Micro, For Clinical Use
Public Device Record Key
8efa8de0-447c-4731-b719-7f8e4100f118
Public Version Date
July 06, 2018
Public Version Number
3
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 |