Duns Number:606814960
Device Description: Hitergent for Roche / Hitachi 900 Series
Catalog Number
16-222
Brand Name
Phoenix Diagnostics
Version/Model Number
16-222
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
JCB
Product Code Name
Detergent
Public Device Record Key
d78446fd-d809-400e-aed5-a03d7c24f48e
Public Version Date
March 30, 2020
Public Version Number
4
DI Record Publish Date
August 12, 2017
Package DI Number
08533660072244
Quantity per Package
14
Contains DI Package
00853366007240
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 |