Brand Name | DTX SAFEDRAW KITS.GABARITH |
Type of Device | SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE |
Manufacturer (Section D) |
MERIT MEDICAL SINGAPORE |
198 yishun ave 7 |
singapore, 76892 6 |
SN 768926 |
|
MDR Report Key | 12313268 |
MDR Text Key | 266220934 |
Report Number | 8020616-2021-00048 |
Device Sequence Number | 1 |
Product Code |
DXN
|
UDI-Device Identifier | 00884450359792 |
UDI-Public | 884450359792 |
Combination Product (y/n) | N |
PMA/PMN Number | EXEMPT |
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 |
08/02/2021 |
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 | 07/13/2022 |
Device Catalogue Number | 688396/B |
Device Lot Number | C1859367 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/31/2021 |
Initial Date Manufacturer Received |
08/02/2021 |
Initial Date FDA Received | 08/12/2021 |
Supplement Dates Manufacturer Received | 09/06/2021
|
Supplement Dates FDA Received | 09/15/2021
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|