Duns Number:606814960
Device Description: ISE Diluent for Roche / Hitachi 700 & 900 Series Chemistry Systems
Catalog Number
-
Brand Name
PHOENIX DIAGNOSTICS, INC.
Version/Model Number
16-201
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
K013451,K013451
Product Code
PPM
Product Code Name
General Purpose Reagent
Public Device Record Key
12b2eb0a-9b04-4015-9dfd-22b967fe9142
Public Version Date
March 30, 2020
Public Version Number
4
DI Record Publish Date
January 26, 2018
Package DI Number
10853366007155
Quantity per Package
6
Contains DI Package
00853366007158
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| 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 |