Brand Name | CLINITEK STATUS+ |
Type of Device | CLINITEK STATUS+ |
Manufacturer (Section D) |
SIEMENS HEALTHCARE DIAGNOSTICS INC. |
511 benedict avenue |
tarrytown NY 10591 |
|
Manufacturer (Section G) |
SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD. |
northern road |
chilton industrial estate |
sudbury, CO10 2XQ |
UK
CO10 2XQ
|
|
Manufacturer Contact |
tim
krauskopf
|
2 edgewater drive |
norwood, MA 02062
|
6107052212
|
|
MDR Report Key | 13921242 |
MDR Text Key | 297909277 |
Report Number | 3002637618-2022-00021 |
Device Sequence Number | 1 |
Product Code |
JIL
|
UDI-Device Identifier | 00630414574639 |
UDI-Public | 00630414574639 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K091216 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
03/25/2022 |
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 Model Number | 10379675 |
Device Catalogue Number | 10379675 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/02/2022 |
Initial Date FDA Received | 03/26/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |