CitraSure 28-0600-1

GUDID 10840861102720

Fresenius Medical Care Renal Therapies Group, LLC

Medical device disinfection agent

• Primary Device ID: 10840861102720
• NIH Device Record Key: 68322c1e-db82-49e5-936c-b6438e5430ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CitraSure
• Version Model Number: 28-0600-1
• Catalog Number: 28-0600-1
• Company DUNS: 079732391
• Company Name: Fresenius Medical Care Renal Therapies Group, LLC
• 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: 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: 1-800-323-5188
• Email: Customer.service@fmc-na.com
• Phone: 1-800-323-5188
• Email: Customer.service@fmc-na.com
• Phone: 1-800-323-5188
• Email: Customer.service@fmc-na.com
• Phone: 1-800-323-5188
• Email: Customer.service@fmc-na.com
• Phone: 1-800-323-5188
• Email: Customer.service@fmc-na.com
• Phone: 1-800-323-5188
• Email: Customer.service@fmc-na.com
• Phone: 1-800-323-5188
• Email: Customer.service@fmc-na.com
• Phone: 1-800-323-5188
• Email: Customer.service@fmc-na.com
• Phone: 1-800-323-5188
• Email: Customer.service@fmc-na.com
• Phone: 1-800-323-5188
• Email: Customer.service@fmc-na.com
• Phone: 1-800-323-5188
• Email: Customer.service@fmc-na.com
• Phone: 1-800-323-5188
• Email: Customer.service@fmc-na.com
• Phone: 1-800-323-5188
• Email: Customer.service@fmc-na.com
• Phone: 1-800-323-5188
• Email: Customer.service@fmc-na.com

Device Dimensions

• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840861102723 [Primary]
GS1	10840861102720 [Package]; Contains: 00840861102723; Package: Box [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243505

FDA Product Code

• NII: Disinfectant, Dialysate Delivery System

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: 2025-08-08
• Device Publish Date: 2025-07-31

Devices Manufactured by Fresenius Medical Care Renal Therapies Group, LLC

• 00084086113014 - Acid connector cpl 10L jug: 2025-08-11 Acid connector cpl 10L jug
• 00084086113021 - Acid connector guide 1 Gal: 2025-08-11 Acid connector guide 1 Gal
• 10840861102515 - 5008X: 2025-08-11 5008X HD/HDF - Standard Blood Tubing Set
• 10840861102522 - 5008X: 2025-08-11 5008X HD/HDF - with Twister Blood Tubing Set
• 10840861102539 - 5008X: 2025-08-11 5008X HD/HDF - with CLiC Blood Tubing Set
• 10840861102553 - 5008X: 2025-08-11 5008X HD Pre-Flush – Standard Blood Tubing Set
• 10840861102560 - 5008X: 2025-08-11 5008X HD Pre-Flush – Twister Blood Tubing Set
• 10840861102607 - 5008X: 2025-08-11 5008X Venous Pressure Replacement Line with Transducer Protector