Duns Number:002054419
Device Description: Pall LeukoGuard LGB Arterial Line Leukocyte Reduction Filter with Bypass Loop
Catalog Number
LGB
Brand Name
Pall LeukoGuard LGB
Version/Model Number
LGB
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K902518,K902518
Product Code
DTM
Product Code Name
Filter, blood, cardiopulmonary bypass, arterial line
Public Device Record Key
a75be26c-1b98-4cc1-8d5f-16e3e97d83f8
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 21, 2015
Package DI Number
35034480004056
Quantity per Package
8
Contains DI Package
05034480004055
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |