Brand Name | ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM |
Type of Device | AUTOMATED URINALYSIS SYSTEM |
Manufacturer (Section D) |
IRIS INTERNATIONAL |
9172 eton ave |
chatsworth CA 91311 |
|
Manufacturer (Section G) |
IRIS INTERNATIONAL |
9172 eton ave |
|
chatsworth CA 91311 |
|
Manufacturer Contact |
gopal
mohanty
|
9172 eton avenue |
chatsworth, ca, CA 91311
|
8185277379
|
|
MDR Report Key | 5960382 |
MDR Text Key | 55055737 |
Report Number | 2023446-2016-00364 |
Device Sequence Number | 1 |
Product Code |
KQO
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K101852 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
08/27/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | N/A |
Device Catalogue Number | 700-7177-001 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
08/27/2016 |
Initial Date FDA Received | 09/19/2016 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 11/30/2011 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |