Brand Name | MICROLAB |
Type of Device | SPIROMETER, DIAGNOSTIC |
Manufacturer (Section D) |
VYAIRE MEDICAL |
22745 savi ranch pkwy |
yorba linda CA 92887 |
|
Manufacturer (Section G) |
VYAIRE MEDICAL GMBH |
leibnizstrasse 7 |
|
hoechberg, 97204 |
GM
97204
|
|
Manufacturer Contact |
peter
sparacio
|
26125 n. riverwoods blvd. |
mettawa, CA 60045
|
8333273284
|
|
MDR Report Key | 10841313 |
MDR Text Key | 217701662 |
Report Number | 9615102-2020-00115 |
Device Sequence Number | 1 |
Product Code |
BZG
|
UDI-Device Identifier | 54250892905551 |
UDI-Public | (01)54250892905551 |
Combination Product (y/n) | N |
Reporter Country Code | FR |
PMA/PMN Number | K141936 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,user facility |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
10/14/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/14/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | FGO MLAB8 SPIROMETER |
Device Catalogue Number | 36-ML3500 MK8-STK |
Was Device Available for Evaluation? |
Yes
|
Date Manufacturer Received | 10/14/2020 |
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|