Duns Number:070371210
Device Description: This product will be used as a concentrated wash solution on automated analyzers. 6 x 25 This product will be used as a concentrated wash solution on automated analyzers. 6 x 25 ml.
Catalog Number
10W500
Brand Name
Wash Concentrate 3
Version/Model Number
10W500
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
-
Product Code
JJF
Product Code Name
Analyzer, Chemistry, Micro, For Clinical Use
Public Device Record Key
32ac3f52-a06a-4573-8a30-f3abba983a8d
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 27, 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 | 38 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 33 |