Pall Posidyne® ELD Filter ELD96LYLS

GUDID 30636207000348

0.2 micron Intravenous Filter for 96 Hour Use with Standard bore Extension Tubing, Y injection site and luer lock adapter

PALL CORPORATION

Intravenous line filter Intravenous line filter Intravenous line filter Intravenous line filter Intravenous line filter Intravenous line filter Intravenous line filter Intravenous line filter Intravenous line filter Intravenous line filter Intravenous line filter Intravenous line filter Intravenous line filter Intravenous line filter Intravenous line filter Intravenous line filter Intravenous line filter Intravenous line filter Intravenous line filter Intravenous line filter Intravenous line filter Intravenous line filter Intravenous line filter Intravenous line filter Intravenous line filter Intravenous line filter Intravenous line filter Intravenous line filter Intravenous line filter Intravenous line filter Intravenous line filter Intravenous line filter

• Primary Device ID: 30636207000348
• NIH Device Record Key: ece7d404-a1de-4da5-8ed2-80cadb6575bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pall Posidyne® ELD Filter
• Version Model Number: ELD96LYLS
• Catalog Number: ELD96LYLS
• Company DUNS: 002054419
• Company Name: PALL CORPORATION
• 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
• Phone: +1(800)645-6578
• Email: QAMedical@pall.com
• Phone: +1(800)645-6578
• Email: QAMedical@pall.com
• Phone: +1(800)645-6578
• Email: QAMedical@pall.com
• Phone: +1(800)645-6578
• Email: QAMedical@pall.com
• Phone: +1(800)645-6578
• Email: QAMedical@pall.com
• Phone: +1(800)645-6578
• Email: QAMedical@pall.com
• Phone: +1(800)645-6578
• Email: QAMedical@pall.com
• Phone: +1(800)645-6578
• Email: QAMedical@pall.com
• Phone: +1(800)645-6578
• Email: QAMedical@pall.com
• Phone: +1(800)645-6578
• Email: QAMedical@pall.com
• Phone: +1(800)645-6578
• Email: QAMedical@pall.com
• Phone: +1(800)645-6578
• Email: QAMedical@pall.com
• Phone: +1(800)645-6578
• Email: QAMedical@pall.com
• Phone: +1(800)645-6578
• Email: QAMedical@pall.com
• Phone: +1(800)645-6578
• Email: QAMedical@pall.com
• Phone: +1(800)645-6578
• Email: QAMedical@pall.com
• Phone: +1(800)645-6578
• Email: QAMedical@pall.com
• Phone: +1(800)645-6578
• Email: QAMedical@pall.com
• Phone: +1(800)645-6578
• Email: QAMedical@pall.com
• Phone: +1(800)645-6578
• Email: QAMedical@pall.com
• Phone: +1(800)645-6578
• Email: QAMedical@pall.com
• Phone: +1(800)645-6578
• Email: QAMedical@pall.com
• Phone: +1(800)645-6578
• Email: QAMedical@pall.com
• Phone: +1(800)645-6578
• Email: QAMedical@pall.com
• Phone: +1(800)645-6578
• Email: QAMedical@pall.com
• Phone: +1(800)645-6578
• Email: QAMedical@pall.com
• Phone: +1(800)645-6578
• Email: QAMedical@pall.com
• Phone: +1(800)645-6578
• Email: QAMedical@pall.com
• Phone: +1(800)645-6578
• Email: QAMedical@pall.com
• Phone: +1(800)645-6578
• Email: QAMedical@pall.com
• Phone: +1(800)645-6578
• Email: QAMedical@pall.com

Device Dimensions

• Pore Size: 0.2 Micrometer
• Pore Size: 0.2 Micrometer
• Pore Size: 0.2 Micrometer
• Pore Size: 0.2 Micrometer
• Pore Size: 0.2 Micrometer
• Pore Size: 0.2 Micrometer
• Pore Size: 0.2 Micrometer
• Pore Size: 0.2 Micrometer
• Pore Size: 0.2 Micrometer
• Pore Size: 0.2 Micrometer
• Pore Size: 0.2 Micrometer
• Pore Size: 0.2 Micrometer
• Pore Size: 0.2 Micrometer
• Pore Size: 0.2 Micrometer
• Pore Size: 0.2 Micrometer
• Pore Size: 0.2 Micrometer
• Pore Size: 0.2 Micrometer
• Pore Size: 0.2 Micrometer
• Pore Size: 0.2 Micrometer
• Pore Size: 0.2 Micrometer
• Pore Size: 0.2 Micrometer
• Pore Size: 0.2 Micrometer
• Pore Size: 0.2 Micrometer
• Pore Size: 0.2 Micrometer
• Pore Size: 0.2 Micrometer
• Pore Size: 0.2 Micrometer
• Pore Size: 0.2 Micrometer
• Pore Size: 0.2 Micrometer
• Pore Size: 0.2 Micrometer
• Pore Size: 0.2 Micrometer
• Pore Size: 0.2 Micrometer
• Pore Size: 0.2 Micrometer

Device Identifiers

Device Issuing Agency	Device ID
GS1	00636207000347 [Primary]
GS1	30636207000348 [Package]; Contains: 00636207000347; Package: case [48 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K850825

FDA Product Code

• FPB: Filter, infusion line

Sterilization

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

[30636207000348]

Ethylene Oxide

[30636207000348]

Ethylene Oxide

[30636207000348]

Ethylene Oxide

[30636207000348]

Ethylene Oxide

[30636207000348]

Ethylene Oxide

[30636207000348]

Ethylene Oxide

[30636207000348]

Ethylene Oxide

[30636207000348]

Ethylene Oxide

[30636207000348]

Ethylene Oxide

[30636207000348]

Ethylene Oxide

[30636207000348]

Ethylene Oxide

[30636207000348]

Ethylene Oxide

[30636207000348]

Ethylene Oxide

[30636207000348]

Ethylene Oxide

[30636207000348]

Ethylene Oxide

[30636207000348]

Ethylene Oxide

[30636207000348]

Ethylene Oxide

[30636207000348]

Ethylene Oxide

[30636207000348]

Ethylene Oxide

[30636207000348]

Ethylene Oxide

[30636207000348]

Ethylene Oxide

[30636207000348]

Ethylene Oxide

[30636207000348]

Ethylene Oxide

[30636207000348]

Ethylene Oxide

[30636207000348]

Ethylene Oxide

[30636207000348]

Ethylene Oxide

[30636207000348]

Ethylene Oxide

[30636207000348]

Ethylene Oxide

[30636207000348]

Ethylene Oxide

[30636207000348]

Ethylene Oxide

[30636207000348]

Ethylene Oxide

[30636207000348]

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: 2016-06-01

On-Brand Devices [Pall Posidyne® ELD Filter]

• 30636207301193: 0.2 micron Intravenous Filter for 96 Hour Use with Standard bore Extension Tubing and Needleless
• 30636207000348: 0.2 micron Intravenous Filter for 96 Hour Use with Standard bore Extension Tubing, Y injection s
• 30636207000331: 0.2 micron Intravenous Filter for 96 Hour Use with Micro-bore Extension Tubing, Y injection site
• 30636207000324: 0.2 micron Intravenous Filter for 96 Hour Use with Micro-bore Extension Tubing an Luer-Lock Adap
• 30636207000126: 0.2 micron Intravenous Filter for 96 Hour Use with Luer-Lock Outlet Port