Brand Name | THE BELMONT RAPID INFUSER |
Type of Device | THERMAL INFUSION FLUID WARMER |
Manufacturer (Section D) |
BELMONT MEDICAL TECHNOLOGIES |
780 boston road |
billerica MA 01821 |
|
Manufacturer (Section G) |
BELMONT MEDICAL TECHNOLOGIES |
780 boston road |
|
billerica MA 01821 |
|
Manufacturer Contact |
sabrina
belladue
|
780 boston road |
billerica, MA 01821
|
9783307637
|
|
MDR Report Key | 9433481 |
MDR Text Key | 194976119 |
Report Number | 1219702-2019-00094 |
Device Sequence Number | 1 |
Product Code |
LGZ
|
UDI-Device Identifier | 00896128002008 |
UDI-Public | 00896128002008 |
Combination Product (y/n) | N |
Reporter Country Code | KS |
PMA/PMN Number | K141654 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,user facility |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
12/06/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/06/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 06/30/2022 |
Device Model Number | 3.0 LITER DISPOSABLE SET |
Device Catalogue Number | 903-00018P |
Device Lot Number | 2019-06 08 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 11/06/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/01/2019 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |