Brand Name | V-SAT VETERINARY SENSOR |
Type of Device | OXIMETER |
Manufacturer (Section D) |
NELLCOR PURITAN BENNETT MEXICO SA |
boulevard insurgentes 19030 |
tijuana 22225 |
MX 22225 |
|
Manufacturer (Section G) |
NELLCOR PURITAN BENNETT MEXICO SA |
boulevard insurgentes 19030 |
|
tijuana 22225 |
MX
22225
|
|
Manufacturer Contact |
avi
kluger
|
5920 longbow drive |
boulder, CO 80301
|
3035306582
|
|
MDR Report Key | 8505786 |
MDR Text Key | 142194911 |
Report Number | 1282497-2019-00017 |
Device Sequence Number | 1 |
Product Code |
DQA
|
UDI-Device Identifier | 10884522042468 |
UDI-Public | 10884522042468 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K162014 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
04/11/2019 |
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 Model Number | V-SAT |
Device Catalogue Number | V-SAT |
Device Lot Number | 180260229H |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/20/2019 |
Initial Date FDA Received | 04/11/2019 |
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 |