Brand Name | SMARTEZ PUMP |
Type of Device | ELASTOMERIC INFUSION PUMP |
Manufacturer (Section D) |
EPIC INTERNATIONAL (THAILAND) CO., LTD. |
hemaraj eastern seaboard indus |
500/73 moo 2, tasit |
pluakdaeng, rayong 21140 |
TH 21140 |
|
Manufacturer (Section G) |
EPIC INTERNATIONAL (THAILAND) CO., LTD. |
hemaraj eastern seaboard indus |
500/73 moo 2, tasit |
pluakdaeng, rayong 21140 |
TH
21140
|
|
Manufacturer Contact |
david
lennarz
|
registrar corp |
144 research dr |
hampton , va 23666
|
7572240177
|
|
MDR Report Key | 8147449 |
MDR Text Key | 129889986 |
Report Number | 3012429465-2018-00004 |
Device Sequence Number | 1 |
Product Code |
MEB
|
UDI-Device Identifier | 28859299101068 |
UDI-Public | (01)28859299101068 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K151650 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign,health pr |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
12/04/2018 |
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 Expiration Date | 07/28/2021 |
Device Model Number | 481062 |
Device Lot Number | S8H02 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/17/2018
|
Initial Date FDA Received | 12/10/2018 |
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 |
|
|