Brand Name | ORIDION MEDICAL |
Type of Device | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE |
Manufacturer (Section D) |
ORIDION MEDICAL |
7 hamarpeh st. |
jerusalem 91235 |
|
Manufacturer (Section G) |
ORIDION MEDICAL |
7 hamarpeh st. |
|
jerusalem 91235 |
|
Manufacturer Contact |
sharon
murphy
|
15 hampshire street |
mansfield, MA 02048
|
2034925267
|
|
MDR Report Key | 6997677 |
MDR Text Key | 91956484 |
Report Number | 8044004-2017-05009 |
Device Sequence Number | 1 |
Product Code |
CCK
|
UDI-Device Identifier | 10884521551503 |
UDI-Public | 10884521551503 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K112368 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer,health professional |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
12/19/2017 |
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 | CS08657-02 |
Device Catalogue Number | CS08657-02 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 11/03/2017 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
10/23/2017 |
Initial Date FDA Received | 11/02/2017 |
Supplement Dates Manufacturer Received | 11/22/2017
|
Supplement Dates FDA Received | 12/19/2017
|
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 |
|
|