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

• 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