Pall LeukoGuard LG

Basic Information

• Brand Name: Pall LeukoGuard LG
• Primary DI: 05034480000408
• Version / Model: LG6B
• Catalog Number: LG6B
• Company Name: Pall International Sàrl
• Labeler DUNS: 485050483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-21
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 067e92c6-b2d1-46c6-ba0b-84833fa811e0

Device Description

Pall LeukoGuard LG Leukocyte Reduction Arterial Blood Filter for Extracorporeal Service (with Bypass Loop)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DTM	Filter, blood, cardiopulmonary bypass, arterial line	Cardiovascular	870.4260	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	35034480000409	GS1	case	6	In Commercial Distribution
Primary	05034480000408	GS1

Customer Contacts

• Phone: [phone] ext. 5164843600
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K902518	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Reduce the levels of circulating leucocytes and exclude microemboli greater than 40 µm in size
Pore Size	40	Micrometer