Brand Name | AIRLIFE® FILTERED SMALL VOLUME NEBULIZER SYSTEM |
Type of Device | NEBULIZER (DIRECT PATIENT INTERFACE) |
Manufacturer (Section D) |
VYAIRE MEDICAL |
26125 n. riverwoods blvd. |
mettawa IL 60045 |
|
Manufacturer (Section G) |
PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V. |
cerrada vía de la producción |
no. 85, parque undustrial |
mexicali 21397 |
MX
21397
|
|
Manufacturer Contact |
erika
bonilla
|
510 technology drive |
irvine, CA 92618
|
|
MDR Report Key | 17051811 |
MDR Text Key | 316430358 |
Report Number | 8030673-2023-00327 |
Device Sequence Number | 1 |
Product Code |
CAF
|
UDI-Device Identifier | 10190752144828 |
UDI-Public | (01)10190752144828 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K874395 |
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 |
Report Date |
06/02/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | AIRLIFE® FILTERED SMALL VOLUME NEBULIZER SYSTEM |
Device Catalogue Number | 124030EU |
Device Lot Number | NOT PROVIDED |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
05/04/2023
|
Initial Date FDA Received | 06/02/2023 |
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 |
Patient Outcome(s) |
Other;
|