Brand Name | MERIT CUSTOM MANIFOLD |
Type of Device | MANIFOLD |
Manufacturer (Section D) |
MERIT MEDICAL SYSTEMS INC. |
1600 merit parkway |
south jordan,, ut |
|
Manufacturer (Section G) |
MERIT MEDICAL SYSTEMS INC. |
1600 merit parkway |
|
south jordan,, ut |
|
Manufacturer Contact |
david
lockridge
|
1600 merit parkway |
south jordan, ut
|
2084551
|
|
MDR Report Key | 10141385 |
MDR Text Key | 196567023 |
Report Number | 1721504-2020-00037 |
Device Sequence Number | 1 |
Product Code |
DQO
|
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
05/13/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/10/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 01/20/2023 |
Device Catalogue Number | 503HN-R/CN |
Device Lot Number | H1757596 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/26/2020 |
Date Manufacturer Received | 05/13/2020 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/05/2020 |
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 |
|
|