Pall Supor® AEF Filter AEF1NTE

GUDID 35034480308826

0.2 micron air eliminating filter with low protein binding Supor membrane for up to 24 hours use. Without attached extension tubing.

Pall International Sàrl

Intravenous line filter

• Primary Device ID: 35034480308826
• NIH Device Record Key: 704c48d9-d97c-42bb-9dc8-f73a42aab5e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pall Supor® AEF Filter
• Version Model Number: AEF1NTE
• Catalog Number: AEF1NTE
• 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	05034480308825 [Primary]
GS1	35034480308826 [Package]; Contains: 05034480308825; 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