Fresenius 04-9500-2

GUDID 20840861100549

Transducer Protectors, bulk pack

Fresenius Medical Care Holdings, Inc.

Haemodialysis system transducer protector

• Primary Device ID: 20840861100549
• NIH Device Record Key: 86475c02-9166-4153-a5e6-a96b5eef3288
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fresenius
• Version Model Number: 04-9500-2
• Catalog Number: 04-9500-2
• Company DUNS: 958291411
• Company Name: Fresenius Medical Care Holdings, Inc.
• Device Count: 100
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840861100545 [Unit of Use]
GS1	10840861100542 [Primary]
GS1	20840861100549 [Package]; Contains: 10840861100542; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003445

FDA Product Code

• FIB: PROTECTOR, TRANSDUCER, DIALYSIS

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2025-08-07
• Device Publish Date: 2015-09-30

On-Brand Devices [Fresenius]

• 10840861100535: Prime Bags, 2-Liter, bulk pack
• 10840861100528: Recirculation connector, bulk pack
• 10840861100511: Priming Set
• 20840861100549: Transducer Protectors, bulk pack