Brand Name | ICHEM VELOCITY STRIP |
Type of Device | URINE CHEMISTRY STRIP |
Manufacturer (Section D) |
IRIS INTERNATIONAL |
9172 eton ave. |
chatsworth CA 91311 |
|
Manufacturer Contact |
gopal
mohanty
|
9172 eton ave. |
chatsworth, CA 91311
|
8185277379
|
|
MDR Report Key | 4863275 |
MDR Text Key | 5864963 |
Report Number | 2023446-2015-00178 |
Device Sequence Number | 1 |
Product Code |
KQO
|
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | K101852 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
05/19/2015 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 01/12/2016 |
Device Catalogue Number | 800-7204 |
Device Lot Number | 7204081A |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
05/19/2015 |
Initial Date FDA Received | 06/18/2015 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 07/17/2015
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 01/12/2015 |
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 |
|
|