5008X Hemodialysis Machine

GUDID 00840861102433

5008X with CLiC and BTM

Fresenius Usa, Inc.

Haemodialysis system, institutional

• Primary Device ID: 00840861102433
• NIH Device Record Key: ee2be037-2d7d-4f05-8545-d9d1f98f5e17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 5008X Hemodialysis Machine
• Version Model Number: M204441
• Company DUNS: 076594100
• Company Name: Fresenius Usa, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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: xxx@xxx.xxx
• Phone: 1 (800) 227-2572
• Email: xxx@xxx.xxx
• Phone: 1 (800) 227-2572
• Email: xxx@xxx.xxx
• Phone: 1 (800) 227-2572
• Email: xxx@xxx.xxx
• Phone: 1 (800) 227-2572
• Email: xxx@xxx.xxx
• Phone: 1 (800) 227-2572
• Email: xxx@xxx.xxx
• Phone: 1 (800) 227-2572
• Email: xxx@xxx.xxx
• Phone: 1 (800) 227-2572
• Email: xxx@xxx.xxx
• Phone: 1 (800) 227-2572
• Email: xxx@xxx.xxx
• Phone: 1 (800) 227-2572
• Email: xxx@xxx.xxx
• Phone: 1 (800) 227-2572
• Email: xxx@xxx.xxx
• Phone: 1 (800) 227-2572
• Email: xxx@xxx.xxx
• Phone: 1 (800) 227-2572
• Email: xxx@xxx.xxx
• Phone: 1 (800) 227-2572
• Email: xxx@xxx.xxx
• Phone: 1 (800) 227-2572
• Email: xxx@xxx.xxx
• Phone: 1 (800) 227-2572
• Email: xxx@xxx.xxx
• Phone: 1 (800) 227-2572
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840861102433 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231534

FDA Product Code

• KDI: Dialyzer, High Permeability With Or Without Sealed Dialysate 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: 2024-05-14
• Device Publish Date: 2024-05-06

Devices Manufactured by Fresenius Usa, Inc.

• 00840861102433 - 5008X Hemodialysis Machine: 2024-05-145008X with CLiC and BTM
• 00840861102433 - 5008X Hemodialysis Machine: 2024-05-14 5008X with CLiC and BTM
• 00840861102280 - VersiPD: 2023-08-09 VersiPD Cart
• 00840861102198 - VersiPD: 2023-02-22 VersiPD Cycler
• 00840861102297 - VersiPD: 2023-02-22 VersiPD Dialysate Solution Bag Case
• 00840861100897 - 2008® Series Hemodialysis Machines: 2018-07-06 2008T HEMODIALYSIS SYS., with CDX
• 00840861100903 - 2008® Series Hemodialysis Machines: 2018-07-06 2008T HEMODIALYSIS SYSTEM WITHOUT CDX
• 00840861100934 - 2008® Series Hemodialysis Machines: 2018-07-06 2008T HD SYSTEM WITH CDX, CANADA
• 00840861100941 - 2008® Series Hemodialysis Machines: 2018-07-06 2008K@HOME HEMODIALYSIS SYSTEM