Brand Name | ABL90 FLEX SP90 |
Type of Device | ABL90 FLEX SOLUTION PACK |
Manufacturer (Section D) |
RADIOMETER MEDICAL APS |
åkandevej 21 |
brønshøj, 2700 |
DA 2700 |
|
Manufacturer (Section G) |
RADIOMETER MEDICAL APS |
åkandevej 21 |
|
brønshøj, 2700 |
DA
2700
|
|
Manufacturer Contact |
tom
engdahl
|
åkandevej 21 |
brønshøj, 2100
|
DA
2100
|
538273827
|
|
MDR Report Key | 6328681 |
MDR Text Key | 67385273 |
Report Number | 3002807968-2017-00004 |
Device Sequence Number | 1 |
Product Code |
CHL
|
UDI-Device Identifier | 05700699441577 |
UDI-Public | (01)05700699441577(17)170401(10)XV06 |
Combination Product (y/n) | N |
Reporter Country Code | AU |
PMA/PMN Number | K132691 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
03/22/2017 |
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 |
Other
|
Device Expiration Date | 06/01/2017 |
Device Model Number | 944-157 |
Device Catalogue Number | 944-157 |
Device Lot Number | XV-06 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
01/21/2017 |
Initial Date FDA Received | 02/14/2017 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 03/22/2017
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 12/01/2016 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
|
|