Brand Name | BIS |
Type of Device | ELECTRODE, CUTANEOUS |
Manufacturer (Section D) |
CELESTICA ELECTRONICS S PTE LTD |
no. 6 serangoon north avenue 5 |
singapore 55491 0 |
SN 554910 |
|
Manufacturer (Section G) |
CELESTICA ELECTRONICS S PTE LTD |
no. 6 serangoon north avenue 5 |
|
singapore 55491 0 |
SN
554910
|
|
Manufacturer Contact |
avi
kluger
|
5920 longbow drive |
boulder, CO 80301
|
3035306582
|
|
MDR Report Key | 11691437 |
MDR Text Key | 259159502 |
Report Number | 2936999-2021-00364 |
Device Sequence Number | 1 |
Product Code |
GXY
|
UDI-Device Identifier | 20884521134307 |
UDI-Public | 20884521134307 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K093183 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
04/19/2021 |
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 | 05/15/2014 |
Device Model Number | 186-0106 |
Device Catalogue Number | 186-0106 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/30/2021 |
Initial Date FDA Received | 04/19/2021 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|