Brand Name | WATER STERILE F/INHALATION 2000ML 6/CS |
Type of Device | STERILE SOLUTION STORAGE BOTTLE, SINGLE-USE |
Manufacturer (Section D) |
VYAIRE MEDICAL |
510 technology dr |
irvine IL 92618 |
|
Manufacturer (Section G) |
LABORATORIOS PISA S.A. DE C.V. |
sa de cv carretera san isidro |
7000 tlajomulco de zúñiga |
jalisco, 45645 |
MX
45645
|
|
Manufacturer Contact |
erika
bonilla
|
510 technology dr |
irvine, IL 92618
|
7149227837
|
|
MDR Report Key | 14459425 |
MDR Text Key | 300324152 |
Report Number | 3007502289-2022-00006 |
Device Sequence Number | 1 |
Product Code |
BTT
|
UDI-Device Identifier | 10885403026607 |
UDI-Public | (01)10885403026607(10)Q2104140 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K090915 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
04/21/2022 |
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 | WATER STERILE F/INHALATION 2000ML 6/CS |
Device Catalogue Number | 2D0737 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/21/2022 |
Initial Date FDA Received | 05/20/2022 |
Supplement Dates Manufacturer Received | 05/26/2022
|
Supplement Dates FDA Received | 06/16/2022
|
Was Device Evaluated by Manufacturer? |
No
|
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 |