Pall® Oxygenator Gas Line Filter ORO1H

GUDID 35034480000447

Bi-directional oxygenator gas line filter for use in gas lines and is indicated for the removal of bacteria, scale and other contaminants from oxygen

Pall International Sàrl

Microbial medical gas filter, sterile, single-use

• Primary Device ID: 35034480000447
• NIH Device Record Key: 9ed37a22-2a66-41dd-85ef-5fa11917fe1e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pall® Oxygenator Gas Line Filter
• Version Model Number: ORO1H
• Catalog Number: ORO1H
• Company DUNS: 485050483
• Company Name: Pall International Sàrl
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• 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

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	05034480000446 [Primary]
GS1	35034480000447 [Package]; Contains: 05034480000446; Package: case [40 Units]; In Commercial Distribution

FDA Product Code

• JQC: CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-07-20

Devices Manufactured by Pall International Sàrl

• 25034480310174 - Pall PharmAssure® Syringe Filter: 2024-03-25 32 mm syringe filter with 1.2 micron low protein binding Supor membrane
• 05034480315601 - Pall QPoint Docking Station Shower: 2019-12-05 Docking Station - White Shower
• 35034480314797 - Pall QPoint® Docking Station Shower: 2019-07-04 Docking Station - Chrome Shower Assembly with Quick Connect Inlet
• 35034480315503 - Pall QPoint® Filter Capsule: 2018-09-06 Pall QPoint® Filter Capsule, Water Filter Capsule for Faucets
• 35034480315510 - Pall QPoint® Filter Capsule: 2018-09-06 Pall QPoint® Filter Capsule, Water Filter Capsule for Faucets
• 35034480315527 - Pall QPoint® Filter Capsule: 2018-09-06 Pall QPoint® Filter Capsule, Water Filter Capsule for Shower
• 35034480315534 - Pall QPoint® Filter Capsule: 2018-09-06 Pall QPoint® Filter Capsule, Water Filter Capsule for Shower
• 35034480000393 - Pall LeukoGuard LG: 2018-07-06 Pall LeukoGuard LG Leukocyte Reduction Arterial Blood Filter for Extracorporeal Service