2008® Series Hemodialysis Machines

GUDID 00840861100941

2008K@HOME HEMODIALYSIS SYSTEM

Fresenius Usa, Inc.

Haemodialysis system, institutional/home-use

• Primary Device ID: 00840861100941
• NIH Device Record Key: ba624e74-0747-4a83-b6e1-3640f558bc29
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 2008® Series Hemodialysis Machines
• Version Model Number: 190828
• Company DUNS: 076594100
• Company Name: Fresenius Usa, Inc.
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840861100941 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070049

FDA Product Code

• ONW: Hemodialysis system for home use

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

On-Brand Devices [2008® Series Hemodialysis Machines]

• 00840861100965: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG
• 00840861100958: 2008K@HOME MACHINE, SHORT CAB, OLC/DP,HP
• 00840861100941: 2008K@HOME HEMODIALYSIS SYSTEM
• 00840861100934: 2008T HD SYSTEM WITH CDX, CANADA
• 00840861100927: 2008T GEN 2 BIBAG WITHOUT CDX
• 00840861100910: 2008T HEMODIALYSIS SYSTEM W/CDX W/BIBAG
• 00840861100903: 2008T HEMODIALYSIS SYSTEM WITHOUT CDX
• 00840861100897: 2008T HEMODIALYSIS SYS., with CDX
• 00840861100873: 2008K2 HEMO SYSTEM, OPTIONAL 5th MODULE
• 00840861100866: 2008K2 MACHINE, SHORT CAB, OLC/DP, HP
• 00840861100859: 2008K2 HEMODIALYSIS SYS. OLC/ DIASAFE PLS