Brand Name | NIPRO ELISIO-H DIALYZER |
Type of Device | DIALYZER |
Manufacturer (Section D) |
NIPRO CORPORATION (ODATE) |
8-7 hanuki-yachi, nilda-aza |
ohdate-shi, akita, 01857 94 |
JA 0185794 |
|
Manufacturer (Section G) |
NIPRO CORPORATION (ODATE) |
8-7 hanuki-yachi, nilda-aza |
|
ohdate-shi, akita, 01857 94 |
JA
0185794
|
|
Manufacturer Contact |
michelle
tejada
|
3150 nw 107 avenue |
miami, FL 33172
|
3055997174
|
|
MDR Report Key | 9370490 |
MDR Text Key | 167968575 |
Report Number | 9610987-2019-00013 |
Device Sequence Number | 1 |
Product Code |
KDI
|
Combination Product (y/n) | N |
Reporter Country Code | IS |
PMA/PMN Number | K131935 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
11/25/2019 |
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 Expiration Date | 11/30/2023 |
Device Model Number | ELISIO-21H |
Device Lot Number | 18L06E |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/22/2019 |
Initial Date FDA Received | 11/25/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 12/06/2018 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|