AccessGUDID - DEVICE: Pall LeukoGuard LG (05034480000392)

GUDID

Device Identifier (DI) Information

Brand Name: Pall LeukoGuard LG
Version or Model: LG6
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LG6
Company Name: Pall International Sàrl

Primary DI Number: 05034480000392
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 485050483 *Terms of Use

Device Description: Pall LeukoGuard LG Leukocyte Reduction Arterial Blood Filter for Extracorporeal Service

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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.	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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

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

Public Device Record Key: 80a04a32-7ae3-46d7-9680-72ff142a666d
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 21, 2015