5008X

GUDID 10840861102621

5008X HD/HDF Medication Line

Fresenius Medical Care Renal Therapies Group, LLC

Haemodialysis blood tubing set, single-use

• Primary Device ID: 10840861102621
• NIH Device Record Key: 23920bff-9bc6-40f5-836b-1258cbb75b4b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 5008X
• Version Model Number: 04-3000-9
• 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) 227-2572
• Email: xx@xx.xx
• Phone: 1 (800) 227-2572
• Email: xx@xx.xx
• Phone: 1 (800) 227-2572
• Email: xx@xx.xx
• Phone: 1 (800) 227-2572
• Email: xx@xx.xx
• Phone: 1 (800) 227-2572
• Email: xx@xx.xx
• Phone: 1 (800) 227-2572
• Email: xx@xx.xx
• Phone: 1 (800) 227-2572
• Email: xx@xx.xx
• Phone: 1 (800) 227-2572
• Email: xx@xx.xx
• Phone: 1 (800) 227-2572
• Email: xx@xx.xx
• Phone: 1 (800) 227-2572
• Email: xx@xx.xx
• Phone: 1 (800) 227-2572
• Email: xx@xx.xx
• Phone: 1 (800) 227-2572
• Email: xx@xx.xx
• Phone: 1 (800) 227-2572
• Email: xx@xx.xx

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Protect from moisture, freezing and excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Protect from moisture, freezing and excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Protect from moisture, freezing and excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Protect from moisture, freezing and excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Protect from moisture, freezing and excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Protect from moisture, freezing and excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Protect from moisture, freezing and excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Protect from moisture, freezing and excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Protect from moisture, freezing and excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Protect from moisture, freezing and excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Protect from moisture, freezing and excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Protect from moisture, freezing and excessive heat.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840861102624 [Primary]
GS1	10840861102621 [Package]; Contains: 00840861102624; Package: [200 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243505

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-11
• Device Publish Date: 2025-08-01

On-Brand Devices [5008X]

• 10840861102621: 5008X HD/HDF Medication Line
• 10840861102607: 5008X Venous Pressure Replacement Line with Transducer Protector
• 10840861102560: 5008X HD Pre-Flush – Twister Blood Tubing Set
• 10840861102553: 5008X HD Pre-Flush – Standard Blood Tubing Set
• 10840861102539: 5008X HD/HDF - with CLiC Blood Tubing Set
• 10840861102522: 5008X HD/HDF - with Twister Blood Tubing Set
• 10840861102515: 5008X HD/HDF - Standard Blood Tubing Set