Ultipor™ Anesthesia Breathing Circuit System - Pediatric size Patient Kit VMPKPED

GUDID 30636207315329

Pediatric Vanilla-Scented Face Mask, Ported Elbow and Ultipor 25 Filter. Non-Conductive, Disposable.

PALL CORPORATION

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• Primary Device ID: 30636207315329
• NIH Device Record Key: e5e09a04-a438-4dd3-8d19-0880c782bf1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultipor™ Anesthesia Breathing Circuit System - Pediatric size Patient Kit
• Version Model Number: VMPKPED
• Catalog Number: VMPKPED
• 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: true
• 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

Device Dimensions

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• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00636207315328 [Primary]
GS1	30636207315329 [Package]; Contains: 00636207315328; Package: case [20 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-06-29

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• 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.