Pall 6254185

GUDID 35034480315107

Transducer Protector Hydrophobic Vent Filter (female and male slip luer)

Pall International Sàrl

Haemodialysis system transducer protector

• Primary Device ID: 35034480315107
• NIH Device Record Key: 5691c7df-882a-4948-a675-83b0604adadc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pall
• Version Model Number: 6254185
• Catalog Number: 6254185
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)645-6578
• Email: EURegulatory@europe.pall.com

Device Dimensions

• Pore Size: 0.2 Micrometer
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	05034480315106 [Primary]
GS1	35034480315107 [Package]; Contains: 05034480315106; Package: case [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K910821

FDA Product Code

• FIB: PROTECTOR, TRANSDUCER, DIALYSIS

Sterilization

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

[35034480315107]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-21

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