Brand Name | PERCUPUMP TOUCHSCREEN INJECTOR SYSTEM W/EDA |
Type of Device | CT INJECTOR W/EXTRAVASATION ACCESSORY |
Baseline Brand Name | PERCUPUMP TOUCHSCREEN INJECTOR W/EDA |
Baseline Generic Name | CT INJECTOR SYSTEM |
Baseline Catalogue Number | 7805 |
Baseline Device Family | PERCUPUMP INJECTOR SYSTEM |
Baseline Device 510(K) Number | K961845 |
Baseline Device PMA Number | |
Baseline Preamendment? |
No
|
Transitional? |
No
|
510(K) Exempt? |
No
|
Shelf Life(Months) | NA |
Date First Marketed | 07/06/1998 |
Manufacturer (Section F) |
E-Z-EM, INC. |
113-117 magnolia ave. |
westbury NY 11590 |
|
Manufacturer (Section D) |
E-Z-EM, INC. |
113-117 magnolia ave. |
westbury NY 11590 |
|
Manufacturer (Section G) |
E-Z-EM, INC. |
717 main st. |
|
westbury NY 11590 |
|
Manufacturer Contact |
gina
vogelsberg
|
717 main street |
westbury
, NY 11590 |
(516)
333
-8230
|
|
Device Event Key | 181825 |
MDR Report Key | 187057 |
Event Key | 175869 |
Report Number | 2432460-1998-00011 |
Device Sequence Number | 1 |
Product Code | FIH |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User facility,Company Representative
|
Reporter Occupation |
Other
|
Remedial Action |
Patient Monitoring
|
Type of Report
| Initial,Followup |
Report Date |
08/11/1998 |
1 Device Was Involved in the Event | |
1 Patient Was Involved in the Event | |
Date FDA Received | 09/11/1998 |
Is This An Adverse Event Report? |
Yes
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 7805 |
Was Device Available For Evaluation? |
No
|
Is The Reporter A Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Distributor Facility Aware Date | 08/11/1998 |
Device Age | 3 mo |
Event Location |
Hospital
|
Date Report TO Manufacturer | 08/11/1998 |
Date Manufacturer Received | 08/11/1998 |
Was Device Evaluated By Manufacturer? |
Yes
|
Date Device Manufactured | 05/01/1998 |
Is The Device Single Use? |
No
|
Is the Device an Implant? |
No
|
Is this an Explanted Device? |
|
Type of Device Usage |
Reuse
|