Ultipor™ Anesthesia Breathing Circuit System - CO2 Monitoring Line CO2GSL060

GUDID 30636207315398

3 Meter CO2 Monitoring Line (0.060” ID) Non-Conductive, Disposable

PALL CORPORATION

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• Primary Device ID: 30636207315398
• NIH Device Record Key: 4bc743ec-f2a0-41de-9c2a-527d7cd1602f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultipor™ Anesthesia Breathing Circuit System - CO2 Monitoring Line
• Version Model Number: CO2GSL060
• Catalog Number: CO2GSL060
• 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: true
• Expiration Date: false
• 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
• 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

• Length: 3 Meter
• Length: 3 Meter
• Length: 3 Meter
• Length: 3 Meter
• Length: 3 Meter
• Length: 3 Meter
• Length: 3 Meter
• Length: 3 Meter
• Length: 3 Meter
• Length: 3 Meter
• Length: 3 Meter
• Length: 3 Meter
• Length: 3 Meter
• Length: 3 Meter
• Length: 3 Meter
• Length: 3 Meter
• Length: 3 Meter
• Length: 3 Meter
• Length: 3 Meter
• Length: 3 Meter
• Length: 3 Meter
• Length: 3 Meter
• Length: 3 Meter
• Length: 3 Meter
• Length: 3 Meter
• Length: 3 Meter
• Length: 3 Meter
• Length: 3 Meter
• Length: 3 Meter
• Length: 3 Meter
• Length: 3 Meter
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• Length: 3 Meter
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• Length: 3 Meter
• Length: 3 Meter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00636207315397 [Primary]
GS1	30636207315398 [Package]; Contains: 00636207315397; Package: case [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013093

FDA Product Code

• CAH: Filter, bacterial, breathing-circuit

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-08-21
• Device Publish Date: 2016-06-29

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• 15034480315882 - Pall Oxygenator Gas Line Filter: 2022-05-04 Bi-directional oxygenator gas line filter for use in gas lines and is indicated for the removal of bacteria, scale and other con
• 00860007036101 - Pall Ultipor 50: 2022-04-28 Breathing Circuit Filter and Heat and Moisture Exchanger
• 15034480315868 - Pall Ultipor 50: 2022-04-28 Breathing Circuit Filter and Heat and Moisture Exchanger
• 30636207302435 - Pall® CellWash/Infusion Bag Set: 2019-09-23 Two empty transfer bags with two spikes and luer adapter and associated tubing for washing blood and cellular components.
• 30636207302442 - Pall® Transfer/Freezing Bag Set: 2019-09-23 Two transfer bags (150 mL and 200 mL) and one 25 mL freezing bag for blood component processing and freezing.
• 30636207302466 - Pall® Freezing Bag 25 mL with Separable Chamber: 2019-09-23 25 mL Freezing Bag with Separable Chamber for blood component freezing.