CAREline 0342501

GUDID 00840861100415

Fresenius Medical Care Holdings, Inc.

Haemodialysis blood tubing set, single-use

• Primary Device ID: 00840861100415
• NIH Device Record Key: 49a4595b-9000-4438-a79a-5dd3013f5434
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAREline
• Version Model Number: 0342501
• Catalog Number: 0342501
• Company DUNS: 958291411
• Company Name: Fresenius Medical Care Holdings, 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: 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: xx@xx.xx
• Phone: +1(800)323-5188
• Email: xx@xx.xx
• Phone: +1(800)323-5188
• Email: xx@xx.xx
• Phone: +1(800)323-5188
• Email: xx@xx.xx
• Phone: +1(800)323-5188
• Email: xx@xx.xx
• Phone: +1(800)323-5188
• Email: xx@xx.xx
• Phone: +1(800)323-5188
• Email: xx@xx.xx
• Phone: +1(800)323-5188
• Email: xx@xx.xx
• Phone: +1(800)323-5188
• Email: xx@xx.xx
• Phone: +1(800)323-5188
• Email: xx@xx.xx
• Phone: +1(800)323-5188
• Email: xx@xx.xx
• Phone: +1(800)323-5188
• Email: xx@xx.xx
• Phone: +1(800)323-5188
• Email: xx@xx.xx
• Phone: +1(800)323-5188
• Email: xx@xx.xx
• Phone: +1(800)323-5188
• Email: xx@xx.xx
• Phone: +1(800)323-5188
• Email: xx@xx.xx
• Phone: +1(800)323-5188
• Email: xx@xx.xx
• Phone: +1(800)323-5188
• Email: xx@xx.xx

Device Dimensions

• Total Volume: 126.3 Milliliter
• Total Volume: 126.3 Milliliter
• Total Volume: 126.3 Milliliter
• Total Volume: 126.3 Milliliter
• Total Volume: 126.3 Milliliter
• Total Volume: 126.3 Milliliter
• Total Volume: 126.3 Milliliter
• Total Volume: 126.3 Milliliter
• Total Volume: 126.3 Milliliter
• Total Volume: 126.3 Milliliter
• Total Volume: 126.3 Milliliter
• Total Volume: 126.3 Milliliter
• Total Volume: 126.3 Milliliter
• Total Volume: 126.3 Milliliter
• Total Volume: 126.3 Milliliter
• Total Volume: 126.3 Milliliter
• Total Volume: 126.3 Milliliter
• Total Volume: 126.3 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840861100415 [Primary]
GS1	10840861100412 [Package]; Package: null [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: 3
• Public Version Date: 2019-06-07
• Device Publish Date: 2018-04-17

Devices Manufactured by Fresenius Medical Care Holdings, Inc.

• 10840861102638 - FX CorAL 60 Dialyzer: 2024-03-04
• 10840861102652 - FX CorAL 100 Dialyzer: 2024-03-04
• 10840861102669 - FX CorAL 120 Dialyzer: 2024-03-04
• 10840861102676 - FX CorAL 600 Dialyzer: 2024-03-04
• 10840861102683 - FX CorAL 800 Dialyzer: 2024-03-04
• 10840861102690 - FX CorAL 1000 Dialyzer: 2024-03-04
• 10840861102409 - CombiSet: 2023-10-27
• 10840861102645 - FX CorAL 80 Dialyzer: 2023-10-12