Pall LeukoGuard BC2 BC2B

GUDID 35034480306105

Pall LeukoGuard BC2 Blood Cardioplegia Filter

Pall International Sàrl

Cardiopulmonary bypass system filter, blood/cardioplegia solution

• Primary Device ID: 35034480306105
• NIH Device Record Key: b0f45dc1-16c9-4309-aff7-a1f08844e26a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pall LeukoGuard BC2
• Version Model Number: BC2B
• Catalog Number: BC2B
• Company DUNS: 485050483
• Company Name: Pall International Sàrl
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)645-6578
• Email: EURegulatory@europe.pall.com

Device Dimensions

• Device Size Text, specify: 0
• Pore Size: 40 Micrometer

Device Identifiers

Device Issuing Agency	Device ID
GS1	05034480306104 [Primary]
GS1	35034480306105 [Package]; Contains: 05034480306104; Package: case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K902518

FDA Product Code

• DTM: Filter, blood, cardiopulmonary bypass, arterial line

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[35034480306105]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-21

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