CAREline

Basic Information

• Brand Name: CAREline
• Primary DI: 00840861102075
• Version / Model: 0450007
• Catalog Number: 0450007
• Company Name: Fresenius Medical Care Renal Therapies Group, LLC
• Labeler DUNS: 079732391
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-05-22
• Public Version: 1
• Public Version Date: 2018-06-22
• Public Version Status: New
• Public Device Record Key: b8be9e90-d20f-4f01-917b-5626d6cc4c6a

Device Description

Dialyzer Holder Lock Sleeve

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KOC	ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS	Gastroenterology, Urology	876.5820	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32144	Haemodialysis system dialyser holder	A device used together with certain types of a haemodialysis system that is used to hold dialysers in order to attach the blood lines from the dialyser to the system. The device is typically made of plastic or stainless steel.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10840861102072	GS1	null	12	In Commercial Distribution
Primary	00840861102075	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]