Pall QPoint Docking Station Shower QDSW

GUDID 05034480315601

Docking Station - White Shower

Pall International Sàrl

Microbial water purification filter, non-sterilizable

• Primary Device ID: 05034480315601
• NIH Device Record Key: 9d91daca-b107-4d00-9567-ac9de06516f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pall QPoint Docking Station Shower
• Version Model Number: QDSW
• Catalog Number: QDSW
• Company DUNS: 485050483
• Company Name: Pall International Sàrl
• Device Count: 1
• DM Exempt: false
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05034480315601 [Primary]
GS1	35034480315602 [Package]; Package: [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163609

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-05
• Device Publish Date: 2019-11-27

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