Brand Name | COLLEAGUE 3 VOLUMETRIC INFUSION PUMP |
Type of Device | INFUSION PUMP |
Baseline Brand Name | COLLEAGUE 3 VOLUMETRIC INFUSION PUMP |
Baseline Generic Name | INFUSION PUMP |
Baseline Catalogue Number | 2M8151K |
Baseline Model Number | COLLEAGUE 3 |
Baseline Device Family | COLLEAGUE VOLUMETRIC PUMP |
Baseline Device 510(K) Number | K961703 |
Baseline Device PMA Number | |
Baseline Preamendment? |
No
|
Transitional? |
No
|
510(K) Exempt? |
No
|
Shelf Life(Months) | NA |
Date First Marketed | 07/01/1998 |
Manufacturer (Section F) |
BAXTER HEALTHCARE PTE. LTD. |
2 woodlands industrial park d |
singapore |
SINGAPORE
2573
|
|
Manufacturer (Section D) |
BAXTER HEALTHCARE PTE. LTD. |
2 woodlands industrial park d |
singapore |
SINGAPORE
2573
|
|
Manufacturer (Section G) |
BAXTER HEALTHCARE PTE. LTD. |
2 woodlands industrial park d |
|
singapore |
SINGAPORE
2573
|
|
Manufacturer Contact |
peggi
householder, rn bsn
|
route 120 & wilson road |
round lake
, IL 60073 |
(847)
270
-2999
|
|
Device Event Key | 486639 |
MDR Report Key | 497892 |
Event Key | 472104 |
Report Number | 6000001-2003-09268 |
Device Sequence Number | 1 |
Product Code | FRN |
Report Source |
Manufacturer
|
Source Type |
Company Representative
|
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
11/10/2003 |
1 Device Was Involved in the Event | |
1 Patient Was Involved in the Event | |
Date FDA Received | 11/18/2003 |
Is This An Adverse Event Report? |
No
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device MODEL Number | COLLEAGUE 3 |
Device Catalogue Number | 2M8153 |
Was Device Available For Evaluation? |
Device Returned To Manufacturer
|
Date Returned to Manufacturer | 11/04/2003 |
Is The Reporter A Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 11/10/2003 |
Was Device Evaluated By Manufacturer? |
Yes
|
Date Device Manufactured | 05/01/2001 |
Is The Device Single Use? |
No
|
Is this a Reprocessed and Reused Single-Use Device? |
No
|
Is the Device an Implant? |
No
|
Is this an Explanted Device? |
|
Type of Device Usage |
Reuse
|