Fresenius 04-9300-7

GUDID 10840861100535

Prime Bags, 2-Liter, bulk pack

Fresenius Medical Care Holdings, Inc.

Haemodialysis blood tubing set, single-use

• Primary Device ID: 10840861100535
• NIH Device Record Key: 2bafb0a1-001c-4f8f-93c8-127f655352a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fresenius
• Version Model Number: 04-9300-7
• Catalog Number: 04-9300-7
• 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

Device Dimensions

• Total Volume: 2 Liter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840861100538 [Unit of Use]
GS1	10840861100535 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K962081

FDA Product Code

• FJK: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

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: 2019-06-07
• 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