CAREline 0342006

GUDID 10840861100405

Fresenius Medical Care Renal Therapies Group, LLC

Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use

• Primary Device ID: 10840861100405
• NIH Device Record Key: b7442a4c-d12a-468c-aad5-5c94317c4bf1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAREline
• Version Model Number: 0342006
• Catalog Number: 0342006
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx

Device Dimensions

• Total Volume: 125 Milliliter
• Total Volume: 125 Milliliter
• Total Volume: 125 Milliliter
• Total Volume: 125 Milliliter
• Total Volume: 125 Milliliter
• Total Volume: 125 Milliliter
• Total Volume: 125 Milliliter
• Total Volume: 125 Milliliter
• Total Volume: 125 Milliliter
• Total Volume: 125 Milliliter
• Total Volume: 125 Milliliter
• Total Volume: 125 Milliliter
• Total Volume: 125 Milliliter
• Total Volume: 125 Milliliter
• Total Volume: 125 Milliliter
• Total Volume: 125 Milliliter
• Total Volume: 125 Milliliter
• Total Volume: 125 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840861100408 [Primary]
GS1	10840861100405 [Package]; Contains: 00840861100408; Package: [28 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172238

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: 2018-04-17

On-Brand Devices [CAREline]

• 10840861100405: 0342006
• 10840861102072: Dialyzer Holder Lock Sleeve