Brand Name | VACUETTE TUBE 4 ML CAT SERUM CLOT ACTIVATOR13X75 RED CAP-BLACK RING, NON-RIDGED |
Type of Device | TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION |
Manufacturer (Section D) |
GREINER BIO-ONE NA INC |
4238 capital drive |
monroe NC 28110 |
|
Manufacturer (Section G) |
GREINER BIO-ONE NA INC |
4238 capital drive |
|
monroe NC 28110 |
|
Manufacturer Contact |
manfred
abel
|
4238 capital drive |
monroe, NC 28110
|
7042617800
|
|
MDR Report Key | 10622098 |
MDR Text Key | 211562550 |
Report Number | 1125230-2017-00001 |
Device Sequence Number | 1 |
Product Code |
JKA
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K983952 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
10/02/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 10/02/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 454204 |
Device Catalogue Number | 454204 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 07/24/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |