Duns Number:227530649
Device Description: This product should be used in conjunction with RX daytona plus reagents to clean probes a This product should be used in conjunction with RX daytona plus reagents to clean probes and cuvettes.
Catalog Number
WS8397
Brand Name
AWS
Version/Model Number
WS8397
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
K131554
Product Code
JJE
Product Code Name
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Public Device Record Key
fc1355e4-9ce2-437f-a319-36e3b560996c
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 |