Duns Number:606814960
Device Description: System Cleaning Solution for Roche / Hitachi Chemistry Systems
Catalog Number
-
Brand Name
PHOENIX DIAGNOSTICS, INC.
Version/Model Number
16-221
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JCB
Product Code Name
Detergent
Public Device Record Key
94fe4108-0bff-4175-a6f5-0bed6c6ec1b2
Public Version Date
March 30, 2020
Public Version Number
3
DI Record Publish Date
January 26, 2018
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 | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 37 |