Brand Name | ULTRAFLUX EMIC2 |
Type of Device | SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE |
Manufacturer (Section D) |
ST. WENDEL AG |
frankfurter str. 6-8 |
st. wendel 66606 |
GM 66606 |
|
Manufacturer (Section G) |
ST. WENDEL AG |
frankfurter str. 6-8 |
|
st. wendel 66606 |
GM
66606
|
|
Manufacturer Contact |
jessica
trujillo
|
920 winter st |
waltham, MA 02451
|
6174175172
|
|
MDR Report Key | 18731267 |
MDR Text Key | 335715770 |
Report Number | 3002807005-2024-00005 |
Device Sequence Number | 1 |
Product Code |
FJK
|
Combination Product (y/n) | N |
Reporter Country Code | EZ |
PMA/PMN Number | EUA200149 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
02/19/2024 |
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 Catalogue Number | 01-9771-0 |
Device Lot Number | C2BL17100 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Device Age | MO |
Initial Date Manufacturer Received |
02/02/2024
|
Initial Date FDA Received | 02/19/2024 |
Was Device Evaluated by Manufacturer? |
No
|
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 |
|
|