Brand Name | CAREFLOW¿ |
Type of Device | CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS |
Manufacturer (Section D) |
MERIT MEDICAL SINGAPORE PTE LTD. |
198 yishun ave 7 |
singapore, sgp 76892 6 |
SN 768926 |
|
Manufacturer (Section G) |
MERIT MEDICAL SINGAPORE PTE LTD. |
198 yishun ave 7 |
|
singapore, sgp 76892 6 |
SN
768926
|
|
Manufacturer Contact |
bryson
heaton
|
1600 merit parkway |
south jordan, UT 84095
|
8012084662
|
|
MDR Report Key | 15638444 |
MDR Text Key | 302068031 |
Report Number | 8020616-2022-00098 |
Device Sequence Number | 1 |
Product Code |
FOZ
|
UDI-Device Identifier | 00886333616497 |
UDI-Public | 00886333616497 |
Combination Product (y/n) | Y |
Reporter Country Code | US |
PMA/PMN Number | K033500 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Literature,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
10/05/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 681649 |
Device Catalogue Number | 681649/A |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
10/05/2022 |
Initial Date FDA Received | 10/20/2022 |
Supplement Dates Manufacturer Received | 11/09/2022
|
Supplement Dates FDA Received | 12/01/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
Life Threatening;
|
|
|