Brand Name | SAFEDRAW |
Type of Device | SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE |
Manufacturer (Section D) |
MERIT MEDICAL SINGAPORE PTE LTD. |
198 yishun ave 7 |
singapore, sgp 76892 6 |
SN 768926 |
|
MDR Report Key | 10853983 |
MDR Text Key | 219372709 |
Report Number | 8020616-2020-00072 |
Device Sequence Number | 1 |
Product Code |
DXN
|
UDI-Device Identifier | 00886333620005 |
UDI-Public | 00886333620005 |
Combination Product (y/n) | N |
PMA/PMN Number | K935782 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Type of Report
| Initial,Followup |
Report Date |
11/12/2020 |
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 | 05/16/2022 |
Device Model Number | 682000 |
Device Catalogue Number | 688910/JPA |
Device Lot Number | C1801550 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
11/12/2020 |
Initial Date FDA Received | 11/17/2020 |
Supplement Dates Manufacturer Received | 04/08/2021
|
Supplement Dates FDA Received | 04/14/2021
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|