Duns Number:606814960
Device Description: Multi-Analyte Chemistry Calibrator (1-Point)
Catalog Number
-
Brand Name
PHOENIX DIAGNOSTICS, INC.
Version/Model Number
PH7000
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JIX
Product Code Name
Calibrator, Multi-Analyte Mixture
Public Device Record Key
d7905d5c-7662-42ac-ae3b-bd3026b31dea
Public Version Date
December 21, 2020
Public Version Number
4
DI Record Publish Date
January 26, 2018
Package DI Number
10853366007445
Quantity per Package
10
Contains DI Package
00853366007448
Package Discontinue Date
-
Package Status
In Commercial Distribution
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 |