Pall® Pro-Tec Filter for Pulmonary Function Testin PF30S

GUDID 35034480309144

Pulmonary Function Filter for pulmonary function testing

Pall International Sàrl

Pulmonary function testing filter/mouthpiece

• Primary Device ID: 35034480309144
• NIH Device Record Key: e13998ce-22ea-4032-8395-7ec2202cfed7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pall® Pro-Tec Filter for Pulmonary Function Testin
• Version Model Number: PF30S
• Catalog Number: PF30S
• 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: 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 Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	05034480309143 [Primary]
GS1	35034480309144 [Package]; Contains: 05034480309143; Package: case [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K854062

FDA Product Code

• BZG: SPIROMETER, DIAGNOSTIC

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: 2016-07-20

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