Pall-Aquasafe™ Detachable Shower Rose AQROSEA

GUDID 35034480314803

Detachable Shower Rose - For use with Pall-Aquasafe Water Filter - Faucet (AQ31F1SA) for 31 day use

Pall International Sàrl

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• Primary Device ID: 35034480314803
• NIH Device Record Key: 38990289-a420-47ea-98cd-0a03190ca1ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pall-Aquasafe™ Detachable Shower Rose
• Version Model Number: AQROSEA
• Catalog Number: AQROSEA
• Company DUNS: 485050483
• Company Name: Pall International Sàrl
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05034480314802 [Primary]
GS1	35034480314803 [Package]; Contains: 05034480314802; Package: case [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153434

FDA Product Code

• NHV: SYSTEM, WATER PURIFICATION, GENERAL MEDICAL 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-20

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