DEVICE: Pall LeukoGuard LGB (05034480004055)
Device Identifier (DI) Information
Pall LeukoGuard LGB
LGB
In Commercial Distribution
LGB
Global Life Sciences Solutions USA LLC
LGB
In Commercial Distribution
LGB
Global Life Sciences Solutions USA LLC
Pall LeukoGuard LGB Arterial Line Leukocyte Reduction Filter with Bypass Loop
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
33309 | Cardiopulmonary bypass system filter, arterial blood line |
A sterile, porous device used in the arterial line of an extracorporeal circuit, during a cardiopulmonary bypass procedure, to trap and remove potentially harmful gaseous emboli, aggregated blood constituents, and particles greater than a specified size (e.g., 40 microns) to prevent them from flowing into the bloodstream and obstructing extracorporeal circulation. It is commonly referred to as a bubble trap and will typically be used for a specified length of time (e.g., 6 hours). This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DTM | Filter, blood, cardiopulmonary bypass, arterial line |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K902518 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Pore Size: 40 Micrometer |
Device Size Text, specify: Reduce the levels of circulating leucocytes and exclude microemboli greater than 40 µm in size |
Device Record Status
a75be26c-1b98-4cc1-8d5f-16e3e97d83f8
February 29, 2024
4
October 21, 2015
February 29, 2024
4
October 21, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
35034480004056 | 8 | 05034480004055 | In Commercial Distribution | case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)645-6578
5164843600
QAMedical@pall.com
QAMedical@pall.com