Pall Ultipor 50

GUDID 00860007036101

Breathing Circuit Filter and Heat and Moisture Exchanger

PALL CORPORATION

Heat/moisture exchanger/microbial medical gas filter

• Primary Device ID: 00860007036101
• NIH Device Record Key: 20f1ae66-2bed-4f98-bf17-9d33e6975b64
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pall Ultipor 50
• Version Model Number: U55
• Company DUNS: 002054419
• Company Name: PALL CORPORATION
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860007036101 [Primary]
GS1	20860007036105 [Package]; Package: Case [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211286

FDA Product Code

• CAH: Filter, Bacterial, Breathing-Circuit

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-28
• Device Publish Date: 2022-04-20

On-Brand Devices [Pall Ultipor 50]

• 15034480315868: Breathing Circuit Filter and Heat and Moisture Exchanger
• 00860007036101: Breathing Circuit Filter and Heat and Moisture Exchanger