Brand Name | MERITRANS DTXPLUS |
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 | 12199260 |
MDR Text Key | 265641078 |
Report Number | 8020616-2021-00041 |
Device Sequence Number | 1 |
Product Code |
DXN
|
UDI-Device Identifier | 00884450356098 |
UDI-Public | 884450356098 |
Combination Product (y/n) | N |
PMA/PMN Number | K935782 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,user facility |
Type of Report
| Initial,Followup |
Report Date |
07/20/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/20/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 01/22/2024 |
Device Catalogue Number | 682046/B |
Device Lot Number | C2030195 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/03/2021 |
Date Manufacturer Received | 08/19/2021 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|