Brand Name | GLUCOMMANDER |
Type of Device | PREDICTIVE PULMONARY FUNCTION VALUE CALCULATOR |
Manufacturer (Section D) |
GLYTEC, LLC |
770 pelham road, suite 210 |
greenville SC 29615 |
|
Manufacturer (Section G) |
GLYTEC, LLC. |
770 pelham road, suite 210 |
|
greenville SC 29615 |
|
Manufacturer Contact |
julie
glendrange
|
770 pelham road, suite 210 |
greenville, SC 29615
|
8642634180
|
|
MDR Report Key | 5967144 |
MDR Text Key | 55677419 |
Report Number | 3005853093-2016-00002 |
Device Sequence Number | 1 |
Product Code |
BTY
|
UDI-Device Identifier | 00860057000305 |
UDI-Public | (01)00860057000305(10)3.2 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K113853 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial |
Report Date |
09/21/2016 |
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 | 3.2 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
08/24/2016 |
Initial Date FDA Received | 09/21/2016 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/03/2016 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|