Duns Number:227530649
Device Description: Acid Wash Solution should be used in conjunction with reagents to clean probes and cuvette Acid Wash Solution should be used in conjunction with reagents to clean probes and cuvettes
Catalog Number
RX8129
Brand Name
ACID WASH SOLUTION (WASH SOLN. 3)
Version/Model Number
RX8129
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
-
Product Code
JJE
Product Code Name
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Public Device Record Key
c5f2bae8-15d5-428e-b93a-a8d2a92a9f41
Public Version Date
October 03, 2022
Public Version Number
1
DI Record Publish Date
September 23, 2022
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 |