Brand Name | 2008T HEMODIALYSIS SYS., WITH CDX |
Type of Device | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM |
Manufacturer (Section D) |
CONCORD MANUFACTURING |
4040 nelson avenue |
concord CA 94520 |
|
Manufacturer (Section G) |
CONCORD MANUFACTURING |
director, quality systems |
4040 nelson avenue |
concord CA 94520 |
|
Manufacturer Contact |
matthew
amaral
|
920 winter st. |
waltham, MA 02451
|
7816999758
|
|
MDR Report Key | 8767146 |
MDR Text Key | 150251121 |
Report Number | 2937457-2019-02072 |
Device Sequence Number | 1 |
Product Code |
KDI
|
UDI-Device Identifier | 00840861100897 |
UDI-Public | 00840861100897 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K093902 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,user f |
Reporter Occupation |
Biomedical Engineer
|
Type of Report
| Initial |
Report Date |
07/08/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/08/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 190713 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Device Age | MO |
Date Manufacturer Received | 06/21/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 01/25/2013 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |