Pall Supor® AEF Filter AEF1E

GUDID 35034480104374

0.2 micron air eliminating filter with low protein binding Supor membrane for up to 24 hours use.

Pall International Sàrl

Intravenous line filter

• Primary Device ID: 35034480104374
• NIH Device Record Key: a0c07149-f821-4f56-b617-43c6408d7994
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pall Supor® AEF Filter
• Version Model Number: AEF1E
• Catalog Number: AEF1E
• 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: QAMedical@pall.com

Device Dimensions

• Pore Size: 0.2 Micrometer

Device Identifiers

Device Issuing Agency	Device ID
GS1	05034480104373 [Primary]
GS1	35034480104374 [Package]; Contains: 05034480104373; Package: case [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993379

FDA Product Code

• FPB: Filter, infusion line

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-20

On-Brand Devices [Pall Supor® AEF Filter]

• 35034480308826: 0.2 micron air eliminating filter with low protein binding Supor membrane for up to 24 hours use
• 35034480104374: 0.2 micron air eliminating filter with low protein binding Supor membrane for up to 24 hours use